Blended Collaborative Care for Heart Failure and Co-Morbid Depression

Completed · Phase 2/Phase 3

Conditions studied: Heart Failure, Systolic, Depression, Cardiovascular Disease

In brief

Depression is highly prevalent among patients with heart failure (HF) and associated with lower levels of health-related quality of life and physical functioning, and higher risk of rehospitalization and mortality, and higher health costs. This Project will compare the effectiveness of a "blended" telephone-delivered collaborative care intervention for treating both HF and depression to: (1) collaborative care for HF-alone ("enhanced usual care"; eUC); and (2) doctors' "usual care" for depression (UC). If proven effective and cost-effective, the potentially more powerful, scalable, efficient "blended" care approach for treating HF and co-morbid depression could have profound implications for improving chronic illness care and stimulate development of "blended" interventions for treating other clusters of related medical conditions.

Key facts

Study ID

NCT02044211

Run by

University of Pittsburgh

People needed

756

Starts

2014-02-01

Expected to finish

2020-07-01

Last updated by the study team

2020-08-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Systolic heart failure (documented ejection fraction ≤ 40%).
• HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV.
• Inpatient two-item Patient Health Questionnaire (PHQ-2) screen-positive for depression; or PHQ-2 screen negative for depression and PHQ-9 <5 if non-depressed control.
• PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control.
• No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment).
• Able to be evaluated and treated for depression as an outpatient.
• English speaking, not illiterate, or possessing any other communication barrier.
• Have a household telephone.

You may not qualify if…

• Receiving active treatment for a mood or anxiety disorder from a mental health specialist.
• Unstable medical condition as indicated by history, physical, and/or laboratory findings.
• Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
• Organic mood syndromes, including those secondary to medical illness or drugs.
• Active suicidal ideation.
• Current or history of psychotic illness.
• Current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
• Current alcohol or other substance abuse as evidenced by chart review and the AUDIT-C questionnaire.
• Age ≤ 21 years.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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