Telemonitoring Enhanced Support for Depression Self Management

• ClinicalTrials.gov Identifier: NCT01834534
• Recruitment Status: Completed
• First Posted: April 18, 2013
• Last Update Posted: March 7, 2019
• Sponsor: University of Michigan
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): James Aikens, PhD, University of Michigan

Study Description

Brief Summary:

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.

**In order to participate, subjects must be patients at participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: CarePartners for depression	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 243 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Telemonitoring Enhanced Support for Depression Self Management
• Study Start Date: September 2013
• Actual Primary Completion Date: May 29, 2018
• Actual Study Completion Date: October 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: CarePartners for depression; 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.	Behavioral: CarePartners for depression; Automated telephone calls for depression monitoring and self-management support.
No Intervention: Usual care; Usual medical care.

Outcome Measures

Primary Outcome Measures :

1. Depressive symptom severity [ Time Frame: 12 months after randomization ]
   Patient Health Questionnaire 9 (PHQ-9).

Secondary Outcome Measures :

1. Depression remission rate [ Time Frame: 12 months after randomization ]
   Remission as measured by PHQ-9 <10
2. Depression-related functional impairment [ Time Frame: 12 months after randomization ]
   Sheehan Disability Scale
3. Positive well-being [ Time Frame: 12 months after randomization ]
   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.
4. Health care costs [ Time Frame: 12 months after randomization ]
   Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Additional Inclusion Criteria:

• at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months
• 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
• current PHQ >10 (non-mild depressive symptoms)
• at least 21 years old
• comfortable speaking English
• can use a touch-tone phone
• can identify at least 1 eligible CarePartner
• not in palliative care, on transplant waitlist, or <1 year life expectancy
• free of major cognitive impairment or psychiatrically unstable
• not experiencing domestic abuse or stalking

Exclusion Criteria:

• Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care
• 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
• Unable to speak English
• Not planning to get all or most of care at study site
• Primary care physician not affiliated with study site
• Unable to use telephone to respond to weekly automated self-management support calls
• Unable to nominate an eligible CP

Contacts and Locations

Locations

United States, Michigan

Alcona Health Centers

Alpena, Michigan, United States, 49707

University of Michigan

Ann Arbor, Michigan, United States, 48013

Dua Family Practice

Canton, Michigan, United States, 48187

Morang Chester

Detroit, Michigan, United States, 48224

Hamilton Community Health Network, Inc.

Flint, Michigan, United States, 48505

Cherry Street Health Services

Grand Rapids, Michigan, United States, 49503

Muskegon Family Care

Muskegon Heights, Michigan, United States, 49444

Sponsors and Collaborators

University of Michigan

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: James E Aikens, Ph.D.; University of Michigan
• Principal Investigator: John D Piette, Ph.D.; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2021 Jun 4. doi: 10.1089/tmj.2021.0042. [Epub ahead of print]

• Responsible Party: James Aikens, PhD, Associate Professor of Family Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT01834534
• Other Study ID Numbers: 1R01MH096699 ( U.S. NIH Grant/Contract ); 1R01MH096699-01 ( U.S. NIH Grant/Contract )
• First Posted: April 18, 2013
• Last Update Posted: March 7, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders