NCT01834534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable depression

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4.7 years

First QC Date

September 13, 2012

Last Update Submit

March 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depressive symptom severity

    Patient Health Questionnaire 9 (PHQ-9).

    12 months after randomization

Secondary Outcomes (4)

  • Depression remission rate

    12 months after randomization

  • Depression-related functional impairment

    12 months after randomization

  • Positive well-being

    12 months after randomization

  • Health care costs

    12 months after randomization

Study Arms (2)

CarePartners for depression

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Usual medical care.

Interventions

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

CarePartners for depression

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alcona Health Centers

Alpena, Michigan, 49707, United States

Location

University of Michigan

Ann Arbor, Michigan, 48013, United States

Location

Dua Family Practice

Canton, Michigan, 48187, United States

Location

Morang Chester

Detroit, Michigan, 48224, United States

Location

Hamilton Community Health Network, Inc.

Flint, Michigan, 48505, United States

Location

Cherry Street Health Services

Grand Rapids, Michigan, 49503, United States

Location

Muskegon Family Care

Muskegon Heights, Michigan, 49444, United States

Location

Related Publications (2)

  • Javier SJ, Risbud R, Rossi FS, Slightam C, Aikens J, Guetterman T, Piette JD, Trivedi R. Improving depression management with support from close others: A thematic analysis of individuals with depression and their partners in care. Chronic Illn. 2024 Jun;20(2):283-295. doi: 10.1177/17423953231175690. Epub 2023 Oct 30.

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • James E Aikens, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • John D Piette, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Family Medicine

Study Record Dates

First Submitted

September 13, 2012

First Posted

April 18, 2013

Study Start

September 1, 2013

Primary Completion

May 29, 2018

Study Completion

October 31, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations