Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-10 @ 6:17 PM
Study NCT ID:
NCT03387735
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2017-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Chronic Conditions for Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ocody@wisc.edu', 'phone': '6084772614', 'title': 'CHESS Statistician', 'organization': 'UW Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'We did not have health lab score baseline data for all participants'}}, 'adverseEventsModule': {'timeFrame': 'up to 18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 0, 'seriousNumAtRisk': 168, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 0, 'seriousNumAtRisk': 176, 'deathsNumAffected': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PROMIS Global Health Measure Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline: Mental', 'categories': [{'measurements': [{'value': '46.27', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '46.21', 'spread': '7.16', 'groupId': 'OG001'}]}]}, {'title': '12 Months: Mental', 'categories': [{'measurements': [{'value': '44.92', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '46.38', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Physical', 'categories': [{'measurements': [{'value': '42.40', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '42.35', 'spread': '5.99', 'groupId': 'OG001'}]}]}, {'title': '12 Months: Physical', 'categories': [{'measurements': [{'value': '42.13', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '42.41', 'spread': '6.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and 12 months', 'description': 'Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Psychological Flourishing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '31.55', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '31.12', 'spread': '5.08', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '31.50', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '31.48', 'spread': '5.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Psychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'UCLA Loneliness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.02', 'spread': '5.77', 'groupId': 'OG000'}, {'value': '17.12', 'spread': '6.04', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '16.05', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '16.75', 'spread': '5.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Loneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unhealthy Laboratory Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-months', 'description': "Laboratory scores are obtained from the patient's electronic health record (EHR) including blood pressure, HAC1 for diabetes, cholesterol, BMI. Some participants did not have this data. The final score is a fraction of the number of unhealthy labs over each persons total labs. Scores range from 0 to 1. Higher scores indicate more unhealthy lab records.", 'unitOfMeasure': 'fraction of unhealthy lab scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '4.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Falls were assessed by asking how often the participant had fallen in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen. Falls ranged from 0 to 14.', 'unitOfMeasure': 'falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.10', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '20.58', 'spread': '14.55', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '18.86', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '18.58', 'spread': '14.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Symptom distress is assessed using a combined list of 20 symptoms and chronic conditions from the General Symptom Distress Scale and Bayliss Disease Burden Scale, assessing the severity of distress for each over the past 2 weeks (0=do not have this, 1=not very distressing, and 5=extremely distressing). Scores range from 0 to 100. Higher scores indicate more symptom distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.14', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '13.07', 'spread': '3.88', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '12.70', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '12.56', 'spread': '4.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Medication adherence is assessed with 8 items, 6 based on the Brief Medication Questionnaire by Svarstad et al. We simplified response options so that participants rate how often they had specific issues with medication (1=never and 5=always). On the basis of patients\' experiences, we added 2 original items, "Feels like I no longer need it" and "Feels like I don\'t need the full dose. There were 8 items in total, summed to get a final score. Scores ranged from 8 to 40. Higher scores indicate less medication adherence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Crisis Health Care Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '0.86', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Crisis health care was the total number of urgent care visits, emergency room visits, and hospitalizations combined. Reported is the average count of visits. Higher numbers indicate more visits.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Long-term Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '0.79', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Long-term care was the number of nights spent in assisted living facilities and nursing homes over the past 3 months. Number of nights ranged from 0 to 92. Higher numbers indicate more nights spent.', 'unitOfMeasure': 'nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Falls Requiring Medical Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-months', 'description': 'Falls requiring medical attention was assessed by one item counting the number of times in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen and required medical attention. Falls needing medical attention ranged from 0 to 4.', 'unitOfMeasure': 'falls requiring medical attention', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'FG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment was conducted from January 2018 to December 2019. The intervention period ended in June 2021.', 'preAssignmentDetails': "Two participants signed the consent form and were randomized but did not start the study. One couldn't use the ET website due to macular degeneration. The other one decided he's not interested in using computers and ElderTree."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.\n\nTreatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.'}, {'id': 'BG001', 'title': 'Treatment as Usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nTAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.54', 'spread': '6.45', 'groupId': 'BG000'}, {'value': '75.03', 'spread': '6.27', 'groupId': 'BG001'}, {'value': '74.79', 'spread': '6.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Health Insurance type', 'classes': [{'categories': [{'title': 'Medicare', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Medicaid', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Affordable Care Act', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Military', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Private insurance', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Covered under someone else', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'No insurance', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'NA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one source', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-03', 'size': 703274, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-15T15:16', 'hasProtocol': True}, {'date': '2018-08-28', 'size': 153031, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-14T12:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2017-11-02', 'resultsFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-10', 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Global Health Measure Score', 'timeFrame': 'Measured at baseline and 12 months', 'description': 'Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life.'}, {'measure': 'Psychological Flourishing Scale', 'timeFrame': 'Baseline and 12-months', 'description': 'Psychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being.'}, {'measure': 'UCLA Loneliness Scale', 'timeFrame': 'Baseline and 12-months', 'description': 'Loneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness.'}], 'secondaryOutcomes': [{'measure': 'Unhealthy Laboratory Scores', 'timeFrame': '12-months', 'description': "Laboratory scores are obtained from the patient's electronic health record (EHR) including blood pressure, HAC1 for diabetes, cholesterol, BMI. Some participants did not have this data. The final score is a fraction of the number of unhealthy labs over each persons total labs. Scores range from 0 to 1. Higher scores indicate more unhealthy lab records."}, {'measure': 'Falls', 'timeFrame': 'Baseline and 12-months', 'description': 'Falls were assessed by asking how often the participant had fallen in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen. Falls ranged from 0 to 14.'}, {'measure': 'Symptom Distress', 'timeFrame': 'Baseline and 12-months', 'description': 'Symptom distress is assessed using a combined list of 20 symptoms and chronic conditions from the General Symptom Distress Scale and Bayliss Disease Burden Scale, assessing the severity of distress for each over the past 2 weeks (0=do not have this, 1=not very distressing, and 5=extremely distressing). Scores range from 0 to 100. Higher scores indicate more symptom distress.'}, {'measure': 'Medication Adherence', 'timeFrame': 'Baseline and 12-months', 'description': 'Medication adherence is assessed with 8 items, 6 based on the Brief Medication Questionnaire by Svarstad et al. We simplified response options so that participants rate how often they had specific issues with medication (1=never and 5=always). On the basis of patients\' experiences, we added 2 original items, "Feels like I no longer need it" and "Feels like I don\'t need the full dose. There were 8 items in total, summed to get a final score. Scores ranged from 8 to 40. Higher scores indicate less medication adherence.'}, {'measure': 'Crisis Health Care Visits', 'timeFrame': 'Baseline and 12-months', 'description': 'Crisis health care was the total number of urgent care visits, emergency room visits, and hospitalizations combined. Reported is the average count of visits. Higher numbers indicate more visits.'}, {'measure': 'Long-term Care', 'timeFrame': 'Baseline and 12-months', 'description': 'Long-term care was the number of nights spent in assisted living facilities and nursing homes over the past 3 months. Number of nights ranged from 0 to 92. Higher numbers indicate more nights spent.'}, {'measure': 'Falls Requiring Medical Attention', 'timeFrame': 'Baseline and 12-months', 'description': 'Falls requiring medical attention was assessed by one item counting the number of times in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen and required medical attention. Falls needing medical attention ranged from 0 to 4.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity'], 'conditions': ['Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '39642938', 'type': 'DERIVED', 'citation': 'Gustafson DH Sr, Mares ML, Johnston D, Vjorn OJ, Curtin JJ, Landucci G, Pe-Romashko K, Gustafson DH Jr, Shah DV. An eHealth Intervention to Improve Quality of Life, Socioemotional, and Health-Related Measures Among Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2024 Dec 6;7:e59588. doi: 10.2196/59588.'}, {'pmid': '33605887', 'type': 'DERIVED', 'citation': 'Gustafson DH Sr, Mares ML, Johnston DC, Mahoney JE, Brown RT, Landucci G, Pe-Romashko K, Cody OJ, Gustafson DH Jr, Shah DV. A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 19;10(2):e25175. doi: 10.2196/25175.'}]}, 'descriptionModule': {'briefSummary': "Multiple chronic conditions are common and expensive among patients aged ≥65 and are associated with lower quality of life, poorer response to treatment, worse medical and psychiatric outcomes, higher mortality, and higher costs of care.\n\nThe primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine the effects of ElderTree --a web-based intervention--on health outcomes and healthcare use among older adults with several chronic health conditions, such as diabetes, high blood pressure, high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease, arrhythmia/atrial fibrillation, chronic pain, arthritis.\n\nThe investigator's hypothesis is that patients assigned to TAU+ElderTree will have better quality of life and fewer primary care visits than those assigned to TAU+Internet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are ≥65 years old\n2. have been treated in the University of Wisconsin Health clinics for at least the previous 18 months with no plans to leave during the study period\n3. have 3 or more of the following chronic conditions: hypertension, hyperlipidemia, diabetes, arthritis, BMI over 30, chronic kidney disease, congestive heart failure, arrhythmia/atrial fibrillation, pulmonary heart disease or pulmonary vascular disease, chronic pain, COPD\n4. report no current psychotic disorder that would prevent participation\n5. have no acute medical problem requiring immediate hospitalization\n6. be able to read and sign the consent form in English\n7. have no known terminal illness\n8. be willing to share health-related study data and\n\n * Systolic and diastolic BP\n * Weight\n * BMI\n * HDL/LDL\n * HbA1C\n * pain score\n * lung function\n * health care utilization: number of ER visits, urgent care visits, primary care visits and specialty care visits\n9. allow researchers to share information with their primary care physician'}, 'identificationModule': {'nctId': 'NCT03387735', 'briefTitle': 'Multiple Chronic Conditions for Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology', 'orgStudyIdInfo': {'id': '2017-0849'}, 'secondaryIdInfos': [{'id': 'A195010', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'ENGR\\INDUSTRIAL ENGR\\CHESS', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R01HL134146-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL134146-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment as usual (TAU) + Internet', 'description': 'Patients will be given access to helpful websites such as National Institute on Aging.', 'interventionNames': ['Other: Treatment as usual (TAU) + Internet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment as usual (TAU) + ElderTree', 'description': 'Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.', 'interventionNames': ['Behavioral: TAU + ElderTree']}], 'interventions': [{'name': 'Treatment as usual (TAU) + Internet', 'type': 'OTHER', 'description': 'Patients in this group will receive TAU+internet and links to helpful websites.', 'armGroupLabels': ['Treatment as usual (TAU) + Internet']}, {'name': 'TAU + ElderTree', 'type': 'BEHAVIORAL', 'description': 'For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.\n\nFor the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.', 'armGroupLabels': ['Treatment as usual (TAU) + ElderTree']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David H Gustafson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}