Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 11:10 PM
Study NCT ID:
NCT05448105
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
My Diabetes Care: A Scalability and Usability Study
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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.martinez@vumc.org', 'phone': '615-936-1010', 'title': 'William Martinez, MD, MS', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency.", 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '85.0'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon signed rank test comparing the participants\' SUS scores to the threshold value of 71 indicative of "good" usability.'}], 'paramType': 'MEDIAN', 'timeFrame': 'One month follow-up (t1)', '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 71 or above suggests 'good' usability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '47 participants used to the study intervention during the study period and completed the SUS scale.'}, {'type': 'PRIMARY', 'title': 'System Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month follow-up (t1)', 'description': 'System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'User Experience - Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'Would recommend the intervention to other patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree/ agree', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}, {'title': 'Neutral/ disagree/ strongly disagree', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Would continue to use the intervention in future if it remained available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree/ agree', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Neutral/ disagree/ strongly disagree', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month follow-up (t1)', 'description': 'User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and participants who responded to the items below on the one month follow-up questionnaire (t1).'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline questionnaire (t0)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '13.0'}]}]}, {'title': 'one-month follow-up questionnaire (t1)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '14.0'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': "The Revised Brief Diabetes Knowledge Test (DKT2) is a valid measure of diabetes knowledge. The 14-item questionnaire was designed to assess a patient's understanding of diabetes management. The DKT2 is a uni-dimensional, 14-item scale with scores ranging from 0 to 14 (number of items answered correctly). Higher scores indicate greater knowledge.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Short Diabetes Knowledge Instrument (SDKI) on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care - Diet Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline (t0) questionnaire', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.0'}]}]}, {'title': 'one-month follow-up (T1) questionnaire', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'pValueComment': 'This is calculated p-value. The threshold for significance was less than 0.05.', 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess diet adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "How many of the last SEVEN DAYS have you followed a healthful eating plan?" The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale diet subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care - Exercise Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline (t0) questionnaire', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.5'}]}]}, {'title': 'one-month follow-up (T1) questionnaire', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 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 days completing recommended activities during the past 7 days. The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Care - Glucose Self-monitoring Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline (t0) questionnaire', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '6.0'}]}]}, {'title': 'one-month follow-up (T1) questionnaire', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess glucose self-monitoring adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. The blood-glucose testing subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline questionnaire (t0)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '26.0'}]}]}, {'title': 'one-month follow-up questionnaire (t1)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '27.0'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', '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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Perceived Diabetes Self-Management Scale (PDSMS) on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline questionnaire (t0)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '18.0'}]}]}, {'title': 'one-month follow-up questionnaire (t1)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '16.5'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item scale has item responses range that from 1="none of the time" to 4="all of the time." Responses are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Adherence to Refills and Medications Scale on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'baseline questionnaire (t0)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '10.0'}]}]}, {'title': 'one-month questionnaire follow-up (t1)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000'], 'statisticalMethod': 'paired Wilcoxon signed-rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', '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 is associated with measures of depression and hemoglobin A1c.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period and completed the Problem Areas in Diabetes Scale (PAID-5) on the baseline (t0) and one-month follow-up (t1) questionnaires.'}, {'type': 'SECONDARY', 'title': 'Change in Knowledge of Diabetes Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'Pre-Intervention (t0): Definition of A1c?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Goal range for A1c?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Definition of systolic blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Goal range for systolic blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Definition of LDL cholesterol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Goal range for LDL cholesterol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Definition of urine microalbumin?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Goal range for urine microalbumin?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Definition of BMI?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): Goal range for BMI?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Definition of A1c?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Goal range for A1c?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Definition of systolic blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Goal range for systolic blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Definition of LDL cholesterol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Goal range for LDL cholesterol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Definition of urine microalbumin?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Goal range for urine microalbumin?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Definition of BMI?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Goal range for BMI?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Correct', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Incorrect', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000'], 'pValueComment': 'This is the calculated p-value.', 'groupDescription': 'Analysis for pre-post change in knowledge of definition of A1C', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.55', 'groupIds': ['OG000'], 'groupDescription': 'Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.11', 'groupIds': ['OG000'], 'groupDescription': 'Analysis for pre-post change in knowledge of definition of systolic blood pressure', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.63', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of pre-post change in knowledge of goal range for systolic blood pressure', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.12', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of pre-post change in knowledge of definition of LDL cholesterol', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.33', 'groupIds': ['OG000'], 'groupDescription': 'Analysis for pre-post change in knowledge of goal range for LDL cholesterol', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.23', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of pre-post change in knowledge of definition of urine microalbumin', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.58', 'groupIds': ['OG000'], 'groupDescription': 'Analysis for pre-post change in knowledge of goal range for urine microalbumin', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.00', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of pre-post change in knowledge of definition of body mass index (BMI)', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.27', 'groupIds': ['OG000'], 'groupDescription': 'Analysis for pre-post change in knowledge of goal range for body mass index (BMI)', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': "Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., hemoglobin A1C, blood pressure, low-density lipoprotein, urine microalbumin, and body mass index). Each item has 1 correct answer and several incorrect answers.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was limited to participants that used MDC during the study period.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Readiness for Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'classes': [{'title': 'Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): follow a healthy diet for people with diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): follow a healthy diet for people with diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Intervention (t0): take your medicines every day as prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Post-Intervention (t1): take your medicines every day as prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Contemplation', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Preparation', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Action', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Maintenance', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'Four-item assess the participants\' stage of change based on the Transtheoretical Model (TTM) of behavior change including one item each for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants\' current TTM stage of change across a continuum: (a) Precontemplation \\[worst\\], (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance \\[best\\]. For each item, precontemplation is represented by the response "No, and I do not intend to in the next 6 months"; contemplation is represented by the response "No, but I am thinking about starting in the next 6 months"; Preparation is represented by the response "No, but I am planning to start in the next 30 days"; action is represented by the response "Yes, I have been for less than 6 months"; and maintenance is represented by the response "Yes, I have been for 6 months or more."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is limited to participants that (1) used MDC during the study period AND (2) completed the survey items at the corresponding timepoints pre-intervention (t0) and post-intervention (T1).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the enrolled participants, 63 completed the baseline questionnaire and were then assigned to the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'My Diabetes Care (MDC)', 'description': "Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.\n\nMDC is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Language', 'classes': [{'title': 'English', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Spanish', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-14', 'size': 192636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-09T15:34', 'hasProtocol': True}, {'date': '2022-11-16', 'size': 186810, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-22T15:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-06-23', 'resultsFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability', 'timeFrame': 'One month follow-up (t1)', '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 71 or above suggests 'good' usability."}, {'measure': 'System Usage', 'timeFrame': 'One month follow-up (t1)', 'description': 'System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.'}, {'measure': 'User Experience - Acceptance', 'timeFrame': 'One month follow-up (t1)', 'description': 'User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.'}], 'secondaryOutcomes': [{'measure': 'Change in Diabetes Knowledge', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': "The Revised Brief Diabetes Knowledge Test (DKT2) is a valid measure of diabetes knowledge. The 14-item questionnaire was designed to assess a patient's understanding of diabetes management. The DKT2 is a uni-dimensional, 14-item scale with scores ranging from 0 to 14 (number of items answered correctly). Higher scores indicate greater knowledge."}, {'measure': 'Change in Diabetes Self-Care - Diet Adherence', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess diet adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "How many of the last SEVEN DAYS have you followed a healthful eating plan?" The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).'}, {'measure': 'Change in Diabetes Self-Care - Exercise Adherence', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 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 days completing recommended activities during the past 7 days. The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).'}, {'measure': 'Change in Diabetes Self-Care - Glucose Self-monitoring Adherence', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess glucose self-monitoring adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. The blood-glucose testing subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).'}, {'measure': 'Change in Diabetes Self-Efficacy', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', '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."}, {'measure': 'Change in Medication Adherence', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item scale has item responses range that from 1="none of the time" to 4="all of the time." Responses 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 (t0) to one month follow-up (t1)', '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 is associated with measures of depression and hemoglobin A1c.'}, {'measure': 'Change in Knowledge of Diabetes Measures', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': "Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., hemoglobin A1C, blood pressure, low-density lipoprotein, urine microalbumin, and body mass index). Each item has 1 correct answer and several incorrect answers."}, {'measure': 'Change in Diabetes Readiness for Change', 'timeFrame': 'Baseline (t0) to one month follow-up (t1)', 'description': 'Four-item assess the participants\' stage of change based on the Transtheoretical Model (TTM) of behavior change including one item each for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants\' current TTM stage of change across a continuum: (a) Precontemplation \\[worst\\], (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance \\[best\\]. For each item, precontemplation is represented by the response "No, and I do not intend to in the next 6 months"; contemplation is represented by the response "No, but I am thinking about starting in the next 6 months"; Preparation is represented by the response "No, but I am planning to start in the next 30 days"; action is represented by the response "Yes, I have been for less than 6 months"; and maintenance is represented by the response "Yes, I have been for 6 months or more."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Self-efficacy', 'Patient Web Portals'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.', 'detailedDescription': "Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate and tailored diabetes selfcare information. Patients will be invited by mail to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete a baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to MDC for 1 month."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Age 18-75 years old\n* Currently taking at least one medication for diabetes\n* Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital\n* Able to speak and read in English or Spanish\n* Reliable access to a smartphone or tablet with internet access\n* Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)\n\nExclusion Criteria:\n\n* Have a medical condition that affects your memory or ability to think\n* Have severe difficulty seeing or hearing\n* Have a medical condition that makes it hard for people to understand what you are saying"}, 'identificationModule': {'nctId': 'NCT05448105', 'briefTitle': 'My Diabetes Care: A Scalability and Usability Study', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'My Diabetes Care: A Scalability and Usability Study', 'orgStudyIdInfo': {'id': '220629'}, 'secondaryIdInfos': [{'id': 'R01DK131129', 'link': 'https://reporter.nih.gov/quickSearch/R01DK131129', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My Diabetes Care (MDC)', 'description': 'Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.', 'interventionNames': ['Other: My Diabetes Care (MDC)']}], 'interventions': [{'name': 'My Diabetes Care (MDC)', 'type': 'OTHER', 'otherNames': ['Patient-facing Diabetes Dashboard'], 'description': "My Diabetes Care (MDC) is a multi-faceted patient portal intervention that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency.", 'armGroupLabels': ['My Diabetes Care (MDC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '37232', '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'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Deidentified individual participant data that underlie the results reported will be available after publication in a peer-reviewed journal and posted on clinical trials and ending after 36 months of publication.', 'ipdSharing': 'YES', 'description': 'After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.', 'accessCriteria': 'Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'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'}}}}