Telemonitoring Enhanced Support for Depression Self Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CarePartners for depression

Intervention Type BEHAVIORAL

Automated telephone calls for depression monitoring and self-management support.

Usual care

Usual medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CarePartners for depression

Automated telephone calls for depression monitoring and self-management support.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No