Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT01834534
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemonitoring Enhanced Support for Depression Self Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptom severity', 'timeFrame': '12 months after randomization', 'description': 'Patient Health Questionnaire 9 (PHQ-9).'}], 'secondaryOutcomes': [{'measure': 'Depression remission rate', 'timeFrame': '12 months after randomization', 'description': 'Remission as measured by PHQ-9 \\<10'}, {'measure': 'Depression-related functional impairment', 'timeFrame': '12 months after randomization', 'description': 'Sheehan Disability Scale'}, {'measure': 'Positive well-being', 'timeFrame': '12 months after randomization', 'description': 'Positive well-being will be assessed using the REMIT, a 5-item scale of positive affect and other aspects of depression recovery developed by the PI and his colleagues. Reference: Nease DE, Jr., Aikens, JE, Klinkman, MK, Kroenke, K, and Sen, A. Toward a more comprehensive assessment of depression remission: the Remission Evaluation and Mood Inventory Tool (REMIT). Journal of General Hospital Psychiatry. 2011.'}, {'measure': 'Health care costs', 'timeFrame': '12 months after randomization', 'description': 'Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '37904531', 'type': 'DERIVED', 'citation': 'Javier SJ, Risbud R, Rossi FS, Slightam C, Aikens J, Guetterman T, Piette JD, Trivedi R. Improving depression management with support from close others: A thematic analysis of individuals with depression and their partners in care. Chronic Illn. 2024 Jun;20(2):283-295. doi: 10.1177/17423953231175690. Epub 2023 Oct 30.'}, {'pmid': '34086485', 'type': 'DERIVED', 'citation': 'Aikens JE, Valenstein M, Plegue MA, Sen A, Marinec N, Achtyes E, Piette JD. Technology-Facilitated Depression Self-Management Linked with Lay Supporters and Primary Care Clinics: Randomized Controlled Trial in a Low-Income Sample. Telemed J E Health. 2022 Mar;28(3):399-406. doi: 10.1089/tmj.2021.0042. Epub 2021 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this research is to test the efficacy of "CarePartners for Depression" (CP-D) intervention, which was designed to increase between visit monitoring of depression status and enhance self-management.\n\n\\*\\*In order to participate, subjects must be patients at participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.', 'detailedDescription': 'This project will test a practical intervention that uses low cost technologies to activate depressed patients\' existing social networks for self-management support. The intervention links patients with a "CarePartner" (CP), i.e., a non-household family member or close friend who is willing to support the patient in coordination with the clinician and any existing in-home caregiver (ICG). Through weekly automated telemonitoring, patients report their mood and self-management status, and receive tailored guidance on self-management. The CP receives a corresponding update along with guidance on how to best support the patient\'s self-management efforts, and the primary care team is notified about clinically urgent situations. The intervention will be tested among depressed primary care patients from clinics serving low-income and underinsured patients, whom the intervention was especially designed to benefit. Specific Aim 1 is to conduct a randomized controlled trial to compare the effectiveness of one year of telemonitoring-supported CP for depression versus usual care (control) on depression severity. Specific Aim 2 is to examine key secondary outcomes (response and remission, impairment, well-being, caregiving burden, healthcare costs) and potential moderators. Specific Aim 3 is to use a mixed-methods approach to enrich our interpretation of the statistical associations, and to discover strategies to enhance the intervention\'s acceptability, effectiveness, and sustainability. If the intervention proves effective without increasing clinician burden or marginal costs, then its subsequent implementation could yield major public health benefits, especially in medically underserved populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'NOTE: In order to participate, must have received medical care for past year at one of the participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester\n\nAdditional Inclusion Criteria:\n\n* at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months\n* depression diagnosis in medical chart problem list or billing record (ICD9 codes: 296.20-.26, .30-.36, 296.4-.9, 298.0, 300.4, 309.0-.1, 309.28, 311.00) during the past 2 years\n* current PHQ \\>10 (non-mild depressive symptoms)\n* at least 21 years old\n* comfortable speaking English\n* can use a touch-tone phone\n* can identify at least 1 eligible CarePartner\n* not in palliative care, on transplant waitlist, or \\<1 year life expectancy\n* free of major cognitive impairment or psychiatrically unstable\n* not experiencing domestic abuse or stalking\n\nExclusion Criteria:\n\n* Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care\n* At risk for domestic abuse, PHQ\\<10, end stage renal disease, lung cancer, dementia, bipolar disease, schizophrenia, limited life expectancy (advanced stage cancer/heart failure/on oxygen), alcohol problems, receiving palliative care\n* Unable to speak English\n* Not planning to get all or most of care at study site\n* Primary care physician not affiliated with study site\n* Unable to use telephone to respond to weekly automated self-management support calls\n* Unable to nominate an eligible CP'}, 'identificationModule': {'nctId': 'NCT01834534', 'briefTitle': 'Telemonitoring Enhanced Support for Depression Self Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Telemonitoring Enhanced Support for Depression Self Management', 'orgStudyIdInfo': {'id': '1R01MH096699', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH096699', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01MH096699-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH096699-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CarePartners for depression', 'description': "For one year, patients receive weekly automated telemonitoring of mood and self-management, while their CarePartners receive weekly reports of the patient's assessment results with tailored instructions on supporting the patient's depression self-management.", 'interventionNames': ['Behavioral: CarePartners for depression']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual medical care.'}], 'interventions': [{'name': 'CarePartners for depression', 'type': 'BEHAVIORAL', 'description': 'Automated telephone calls for depression monitoring and self-management support.', 'armGroupLabels': ['CarePartners for depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49707', 'city': 'Alpena', 'state': 'Michigan', 'country': 'United States', 'facility': 'Alcona Health Centers', 'geoPoint': {'lat': 45.06168, 'lon': -83.43275}}, {'zip': '48013', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48187', 'city': 'Canton', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dua Family Practice', 'geoPoint': {'lat': 42.30865, 'lon': -83.48216}}, {'zip': '48224', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Morang Chester', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48505', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamilton Community Health Network, Inc.', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cherry Street Health Services', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49444', 'city': 'Muskegon Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Muskegon Family Care', 'geoPoint': {'lat': 43.20113, 'lon': -86.23895}}], 'overallOfficials': [{'name': 'James E Aikens, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'John D Piette, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Family Medicine', 'investigatorFullName': 'James Aikens, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}