Blended Collaborative Care for Heart Failure and Co-Morbid Depression
1 other identifier
interventional
756
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2014
Longer than P75 for phase_2
1 active site
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
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 5, 2020
August 1, 2020
4.7 years
January 21, 2014
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Mental Health-Related Quality of Life
12-Months Follow-Up
Secondary Outcomes (6)
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
12-Month Follow-Up
Hamilton Rating Scale for Depression (17-Item)
12-Months Follow-Up
Incidence of Rehospitalization
12-Month Follow-Up
Mortality
12-Month Follow-Up
Health Care Costs
12-Month Follow-Up
- +1 more secondary outcomes
Study Arms (4)
Collaborative Care for Heart Failure + Depression
ACTIVE COMPARATORCollaborative 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 Only
ACTIVE COMPARATORCollaborative 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 Depression
NO INTERVENTIONControl group will receive their doctors' usual care for heart failure and depression
Non-Depressed Comparison Cohort
NO INTERVENTIONControl group will receive their doctors' usual care for heart failure
Interventions
Nurse 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.
The 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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (9)
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.
PMID: 27638965BACKGROUNDSchuster JM, Belnap BH, Roth LH, Rollman BL. The Checklist Manifesto in action: integrating depression treatment into routine cardiac care. Gen Hosp Psychiatry. 2016 May-Jun;40:1-3. doi: 10.1016/j.genhosppsych.2016.01.005. Epub 2016 Jan 22. No abstract available.
PMID: 26916974BACKGROUNDHerbeck Belnap B, Anderson A, Abebe KZ, Ramani R, Muldoon MF, Karp JF, Rollman BL. Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial. Psychosom Med. 2019 Jul/Aug;81(6):495-505. doi: 10.1097/PSY.0000000000000706.
PMID: 31083056BACKGROUNDRollman BL. Exercise and Cognitive Training to Improve Neurocognitive Outcomes in Patients With Heart Failure: Can Cardiac Rehabilitation Deliver? Am J Geriatr Psychiatry. 2019 Aug;27(8):820-822. doi: 10.1016/j.jagp.2019.05.001. Epub 2019 May 6. No abstract available.
PMID: 31151835BACKGROUNDBober T, Guhl EN, Rothenberger S, Jeong K, Abebe KZ, Holber J, Anderson AM, Magnani JW, Johnson AE, Rollman BL. Impact of Neighborhood Factors on Heart Failure Outcomes: Secondary Analysis From the Hopeful Heart Trial. JACC Adv. 2025 Oct;4(10 Pt 2):102146. doi: 10.1016/j.jacadv.2025.102146. Epub 2025 Sep 14.
PMID: 40953541DERIVEDCarrillo A, Belnap BH, Rothenberger SD, Feldman R, Rollman BL, Celano CM. Psychosocial predictors of health behavior adherence in heart-failure patients with comorbid depression: a secondary analysis of the Hopeful Heart trial. BMC Psychol. 2024 Jun 4;12(1):328. doi: 10.1186/s40359-024-01816-4.
PMID: 38835104DERIVEDSadlonova M, Chavanon ML, Kwonho J, Abebe KZ, Celano CM, Huffman J, Herbeck Belnap B, Rollman BL. Depression Subtypes in Systolic Heart Failure: A Secondary Analysis From a Randomized Controlled Trial. J Acad Consult Liaison Psychiatry. 2023 Sep-Oct;64(5):444-456. doi: 10.1016/j.jaclp.2023.03.008. Epub 2023 Mar 29.
PMID: 37001642DERIVEDHolber JP, Abebe KZ, Huang Y, Jakicic JM, Anderson AM, Belnap BH, Rollman BL. The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure. Psychosom Med. 2022 Feb-Mar 01;84(2):231-236. doi: 10.1097/PSY.0000000000001034.
PMID: 34724453DERIVEDRollman BL, Anderson AM, Rothenberger SD, Abebe KZ, Ramani R, Muldoon MF, Jakicic JM, Herbeck Belnap B, Karp JF. Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1369-1380. doi: 10.1001/jamainternmed.2021.4978.
PMID: 34459842DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce L. Rollman, MD, MPH
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 23, 2014
Study Start
February 1, 2014
Primary Completion
October 1, 2018
Study Completion
July 1, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08