Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-04 @ 4:40 PM
Study NCT ID:
NCT03947333
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.martinez@vumc.org', 'phone': '(615) 936-1010', 'title': 'William Martinez, MD', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.", 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient Activation at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.6', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.559', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.846', 'ciLowerLimit': '-1.99', 'ciUpperLimit': '3.68', 'groupDescription': 'Mixed effects model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Patient Activation at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3-month follow-up', 'description': "The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.7', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.451', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.348', 'ciLowerLimit': '-0.557', 'ciUpperLimit': '1.254', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. PDSMS has excellent internal consistency reliability (Cronbach's alpha of 0.83). PDSMS scores were associated with observed percentage of low blood sugars (r = .21), BMI (r = -.22), percentage of high blood sugars (r = -.36), average blood glucose (r = -.27), and A1C (r = -.25). Thus, the PDSMS appears to be validly associated with important self-management behaviors as well as with indicators of health status and diabetes control.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the Perceived Diabetes Self-Management Scale (PDSMS) were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '2.0', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.270', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.8', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.7', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '-1.786', 'ciUpperLimit': '1.986', 'groupDescription': 'Mixed effects model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the Short Diabetes Knowledge Instrument (SDKI) were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care (General Diet Adherence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.242', 'ciLowerLimit': '-0.049', 'ciUpperLimit': '0.533', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants with missing responses to items on the 'general diet' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed."}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care (Specific Diet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.183', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '0.451', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The specific diet subscale is used to assess intake of specific foods. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants with missing responses to items on the 'specific diet' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed."}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care (Exercise Adherence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.847', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.031', 'ciLowerLimit': '-0.288', 'ciUpperLimit': '0.351', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants with missing responses to items on the 'exercise' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed."}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.3', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.612', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.107', 'ciLowerLimit': '-0.305', 'ciUpperLimit': '0.519', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The blood-glucose testing subscale was administered only to patients that reported testing their blood sugar at home. Participants with missing responses to items on the 'blood-glucose testing' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed."}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care (Diabetes Medication Adherence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.970', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.5', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.088', 'ciLowerLimit': '-0.493', 'ciUpperLimit': '0.317', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1="none of the time" to 4="all of the time," and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the Adherence to Refills and Medications Scale-Diabetes (ARMS-D) scale were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Change at 3 months', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 months', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0', 'groupDescription': 'Change at 3 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'groupDescription': 'Change at 6 months', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fixed-effects estimate of intervention', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.150', 'ciLowerLimit': '-0.713', 'ciUpperLimit': '0.413', 'groupDescription': 'Mixed Effects Model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the Problem Areas in Diabetes Scale (PAID-5) scale were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Glucose Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.06', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).", 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "If date of the most recent hemoglobin A1c abstracted from the participant's electronic health record at 6 month follow-up was less than 90 or greater than 365 days from the date of the most recent hemoglobin A1c abstracted from the participant's electronic health record at baseline, then the participant was not included in the analysis."}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.04', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3) and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure).", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Flu Vaccination Status for 2019-20 Flu Season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Unvaccinated', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Vaccinated', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': '3 month follow-up', 'categories': [{'title': 'Unvaccinated', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Vaccinated', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.480', 'groupIds': ['OG000'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.023', 'groupIds': ['OG001'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-month follow up', 'description': "The participants' influenza vaccination status (vaccinated vs unvaccinated) for the 2019-20 Flu Season will be abstracted from participants' electronic medical record at enrollment (T0), 3 month follow-up (T1).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Low Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '36.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.542', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.8', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent low density lipoprotein measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "If date of the most recent low density lipoprotein (LDL) abstracted from the participant's electronic health record at 6 month follow-up was less than 90 or greater than 365 days from the date of the most recent LDL abstracted from the participant's electronic health record at baseline, then the participant was not included in the analysis."}, {'type': 'SECONDARY', 'title': 'Satisfaction/Usability of My Health at Vanderbilt (for Control Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '79.0', 'spread': '12.9', 'groupId': 'OG000'}]}]}, {'title': '3 month follow-up', 'categories': [{'measurements': [{'value': '82.4', 'spread': '13.4', 'groupId': 'OG000'}]}]}, {'title': '6 month follow-up', 'categories': [{'measurements': [{'value': '83.2', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the System Usability Scale (SUS) were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Satisfaction/Usability of My Diabetes Care (for Intervention Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}], 'classes': [{'title': '3 month follow-up', 'categories': [{'measurements': [{'value': '73.7', 'spread': '14.3', 'groupId': 'OG000'}]}]}, {'title': '6 month follow-up', 'categories': [{'measurements': [{'value': '71.7', 'spread': '15.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month follow up, 6-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing responses to items on the System Usability Scale (SUS) were not analyzed.'}, {'type': 'SECONDARY', 'title': 'System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'One to three', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Four to six', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Seven to nine', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Ten or more', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}], 'classes': [{'categories': [{'title': '5 minutes or less', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '6 to 10 minutes', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': '11 to 15 minutes', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': '16 to 20 minutes', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'More than 20 minutes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}], 'classes': [{'title': 'Links to information about diabetes', 'categories': [{'title': 'No', 'measurements': [{'value': '67', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Message your Doctor button', 'categories': [{'title': 'No', 'measurements': [{'value': '98', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Online Patient Support Community button', 'categories': [{'title': 'No', 'measurements': [{'value': '119', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Hover over text or icon for more information about your diabetes health data', 'categories': [{'title': 'No', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes News Feeds (Diabetes Views or ADA Diabetes Blog)', 'categories': [{'title': 'No', 'measurements': [{'value': '104', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'None of the above', 'categories': [{'title': 'No', 'measurements': [{'value': '99', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'My Diabetes Care features used at least once by the participant. Rows are not mutually exclusive as participants can use more than one feature. Participants with no response to this questionnaire item were not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '17 participants were administratively withdrawn from the study before assignment to groups because they did not complete the baseline study questionnaire (needed prior to randomization). This included 13 patients that could not be reached after enrollment and 4 patients that were reached but did not return the baseline questionnaire. 270 patients completed the baseline study questionnaire and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.\n\nMy Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability."}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Some high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'High school graduate or GED', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Some college or technical school', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': "College graduate (bachelor's degree)", 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Some graduate work/school', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Graduate degree', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Working full-time, >=35 hours/week', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Working part-time, <35 hours/week', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unemployed or laid off and looking for work', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Homemaker', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'In school', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Retired', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Disabled, not able to work', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Something else', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance', 'classes': [{'title': 'Individual Plan', 'categories': [{'title': 'No', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Group Plan', 'categories': [{'title': 'No', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Governmental Plan', 'categories': [{'title': 'No', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid', 'categories': [{'title': 'No', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Medicare', 'categories': [{'title': 'No', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Uninsured', 'categories': [{'title': 'No', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Rows are not mutually exclusive as participants can have more than one type of insurance', 'unitOfMeasure': 'Participants'}, {'title': 'Health Literacy', 'classes': [{'categories': [{'title': 'Adequate', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Limited', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Duration', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '19'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-08', 'size': 239161, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-08T02:32', 'hasProtocol': True}, {'date': '2020-02-25', 'size': 806555, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-03T00:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2019-05-09', 'resultsFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-03', 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Activation at 6 Months', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization."}, {'measure': 'Change in Patient Activation at 3 Months', 'timeFrame': 'Baseline to 3-month follow-up', 'description': "The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization."}], 'secondaryOutcomes': [{'measure': 'Change in Diabetes Self-Efficacy', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. PDSMS has excellent internal consistency reliability (Cronbach's alpha of 0.83). PDSMS scores were associated with observed percentage of low blood sugars (r = .21), BMI (r = -.22), percentage of high blood sugars (r = -.36), average blood glucose (r = -.27), and A1C (r = -.25). Thus, the PDSMS appears to be validly associated with important self-management behaviors as well as with indicators of health status and diabetes control."}, {'measure': 'Change in Diabetes Knowledge', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014)."}, {'measure': 'Change in Diabetes Self-Care (General Diet Adherence)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).'}, {'measure': 'Change in Diabetes Self-Care (Specific Diet)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The specific diet subscale is used to assess intake of specific foods. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).'}, {'measure': 'Change in Diabetes Self-Care (Exercise Adherence)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).'}, {'measure': 'Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).'}, {'measure': 'Change in Diabetes Self-Care (Diabetes Medication Adherence)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': 'The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1="none of the time" to 4="all of the time," and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.'}, {'measure': 'Change in Diabetes Distress', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c."}, {'measure': 'Change in Blood Glucose Control', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3)."}, {'measure': 'Change in Blood Pressure Control', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3) and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure)."}, {'measure': 'Change in Flu Vaccination Status for 2019-20 Flu Season', 'timeFrame': 'Baseline, 3-month follow up', 'description': "The participants' influenza vaccination status (vaccinated vs unvaccinated) for the 2019-20 Flu Season will be abstracted from participants' electronic medical record at enrollment (T0), 3 month follow-up (T1)."}, {'measure': 'Change in Low Density Lipoprotein', 'timeFrame': 'Baseline to 6-month follow-up', 'description': "Participants' most recent low density lipoprotein measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3)."}, {'measure': 'Satisfaction/Usability of My Health at Vanderbilt (for Control Group)', 'timeFrame': 'Baseline, 3-month follow up, 6-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91)."}, {'measure': 'Satisfaction/Usability of My Diabetes Care (for Intervention Group)', 'timeFrame': '3-month follow up, 6-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91)."}, {'measure': 'System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality"}, {'measure': 'System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality"}, {'measure': 'System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)', 'timeFrame': '6-month follow-up', 'description': "Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Patient Activation', 'Patient Web Portals', 'Health Information Technology'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34032578', 'type': 'DERIVED', 'citation': 'Martinez W, Hackstadt AJ, Hickson GB, Rosenbloom ST, Elasy TA. Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 25;10(5):e25955. doi: 10.2196/25955.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.', 'detailedDescription': "300 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 150 will be assigned to receive access to the intervention (My Diabetes Care) embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 150 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt without the My Diabetes Care. Patients will be invited by mail (or email) to be screened for enrollment in the study. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being randomized to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month and 6-month follow-ups to assess outcomes. In addition, system usage will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Currently being treated with at least one antihyperglycemic medication\n* Able to speak and read in English\n* Reliable access to a computer (desktop or laptop) with internet capabilities\n* Active VUMC patient web portal (known as My Health At Vanderbilt) account\n\nExclusion Criteria:\n\n* Residing in a long term care facility\n* Medical condition that affects my memory or ability to think.\n* Severe visual impairment\n* Currently participating in another diabetes-related research study'}, 'identificationModule': {'nctId': 'NCT03947333', 'briefTitle': 'Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Evaluation of a Patient Portal Intervention for Diabetes: A Two-arm, Parallel-Design, Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '190825'}, 'secondaryIdInfos': [{'id': '5K23DK106511', 'link': 'https://reporter.nih.gov/quickSearch/5K23DK106511', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.', 'interventionNames': ['Other: My Diabetes Care']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).'}], 'interventions': [{'name': 'My Diabetes Care', 'type': 'OTHER', 'otherNames': ['Patient-facing Diabetes Dashboard'], 'description': "The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'William Martinez, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'William Martinez, MD, MS', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}