Telemonitoring Enhanced Support for Depression Self Management

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: CarePartners for depression

• Registration Number: NCT01834534
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-18
• Study Start: 2013-09
• Primary Completion: 2018-05-29
• Study Completion: 2018-10-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CarePartners for depression	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.

Primary Outcome Measures

Name	Time	Method
Depressive symptom severity	12 months after randomization	Patient Health Questionnaire 9 (PHQ-9).

Secondary Outcome Measures

Name	Time	Method
Positive well-being	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.
Health care costs	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.
Depression remission rate	12 months after randomization	Remission as measured by PHQ-9 \<10
Depression-related functional impairment	12 months after randomization	Sheehan Disability Scale

Trial Locations

Locations (7)

Hamilton Community Health Network, Inc.; 🇺🇸 Flint, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Dua Family Practice; 🇺🇸 Canton, Michigan, United States

Muskegon Family Care; 🇺🇸 Muskegon Heights, Michigan, United States

Alcona Health Centers; 🇺🇸 Alpena, Michigan, United States

Morang Chester; 🇺🇸 Detroit, Michigan, United States

Cherry Street Health Services; 🇺🇸 Grand Rapids, Michigan, United States