Telemonitoring Enhanced Support for Depression Self Management

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: CarePartners for depression

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 Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Alcona Health Centers
    • Ann Arbor, Michigan, United States, 48013
      • University of Michigan
    • Canton, Michigan, United States, 48187
      • Dua Family Practice
    • Detroit, Michigan, United States, 48224
      • Morang Chester
    • Flint, Michigan, United States, 48505
      • Hamilton Community Health Network, Inc.
    • Grand Rapids, Michigan, United States, 49503
      • Cherry Street Health Services
    • Muskegon Heights, Michigan, United States, 49444
      • Muskegon Family Care

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptom severity	Patient Health Questionnaire 9 (PHQ-9).	12 months after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1R01MH096699 (U.S. NIH Grant/Contract); 1R01MH096699-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO