Telemonitoring Enhanced Support for Depression Self Management

Depression Clinical Trial

Official title:

Telemonitoring Enhanced Support for Depression Self Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834534
• Other study ID #: 1R01MH096699
• Secondary ID: 1R01MH096699-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 31, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• CarePartners for depression
Automated telephone calls for depression monitoring and self-management support.

Locations

Country	Name	City	State
United States	Alcona Health Centers	Alpena	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Dua Family Practice	Canton	Michigan
United States	Morang Chester	Detroit	Michigan
United States	Hamilton Community Health Network, Inc.	Flint	Michigan
United States	Cherry Street Health Services	Grand Rapids	Michigan
United States	Muskegon Family Care	Muskegon Heights	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptom severity	Patient Health Questionnaire 9 (PHQ-9).	12 months after randomization
Secondary	Depression remission rate	Remission as measured by PHQ-9 <10	12 months after randomization
Secondary	Depression-related functional impairment	Sheehan Disability Scale	12 months after randomization
Secondary	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
Secondary	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