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Heart Failure, Systolic | Blended Collaborative Care for Heart Failure and Co-Morbid Depression

Heart Failure, Systolic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Systolic heart failure (documented ejection fraction ≤ 40%). 2. HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV. 3. 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. 4. PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control. 5. No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment). 6. Able to be evaluated and treated for depression as an outpatient. 7. English speaking, not illiterate, or possessing any other communication barrier. 8. Have a household telephone. Exclusion Criteria: 1. Receiving active treatment for a mood or anxiety disorder from a mental health specialist. 2. Unstable medical condition as indicated by history, physical, and/or laboratory findings. 3. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer). 4. Organic mood syndromes, including those secondary to medical illness or drugs. 5. Active suicidal ideation. 6. Current or history of psychotic illness. 7. Current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria. 8. Current alcohol or other substance abuse as evidenced by chart review and the AUDIT-C questionnaire. 9. Age ≤ 21 years.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Heart Failure, Systolic

Depression

Cardiovascular Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Collaborative Care for Heart FailureNurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments. After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist.

Behavioral:Collaborative Care for DepressionThe care manager will telephone patients randomized to "blended" care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options. They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist. The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Collaborative Care for Heart Failure + DepressionCollaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Counseling for depression Drug: Pharmacotherapy for heart failure Pharmacotherapy for depression

Collaborative Care for Heart Failure OnlyCollaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Usual care for depression Drug: Pharmacotherapy for heart failure Usual Care for depression

Usual Care for Heart Failure and DepressionControl group will receive their doctors' usual care for heart failure and depression

Non-Depressed Comparison CohortControl group will receive their doctors' usual care for heart failure

Study Status

Active, not recruiting

Start Date: February 2014

Completed Date: June 2019

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)

Secondary Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

Study sponsors, principal investigator, and references

Principal Investigator: Bruce L. Rollman, MD, MPH

Lead Sponsor: University of Pittsburgh

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT02044211

Deveney TK, Belnap BH, Mazumdar S, Rollman BL. The prognostic impact and optimal timing of the Patient Health Questionnaire depression screen on 4-year mortality among hospitalized patients with systolic heart failure. Gen Hosp Psychiatry. 2016 Sep-Oct;42:9-14. doi: 10.1016/j.genhosppsych.2016.06.005. Epub 2016 Jun 30.

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