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Blended Collaborative Care for Heart Failure and Co-Morbid Depression

Primary Purpose

Heart Failure, Systolic, Depression, Cardiovascular Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care for Heart Failure
Collaborative Care for Depression
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Heart Failure, Systolic, Depressive Disorder, Depressive Disorder, Major, Mood Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Collaborative Care for Heart Failure + Depression

Collaborative Care for Heart Failure Only

Usual Care for Heart Failure and Depression

Non-Depressed Comparison Cohort

Arm Description

Collaborative 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 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

Control group will receive their doctors' usual care for heart failure and depression

Control group will receive their doctors' usual care for heart failure

Outcomes

Primary Outcome Measures

Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Mental Health-Related Quality of Life

Secondary Outcome Measures

Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Disease-Specific Health-Related Quality of Life
Hamilton Rating Scale for Depression (17-Item)
Mood symptoms
Incidence of Rehospitalization
Mortality
All-Cause and Cardiovascular Mortality
Health Care Costs
Claims data
Employment

Full Information

First Posted
January 21, 2014
Last Updated
August 3, 2020
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02044211
Brief Title
Blended Collaborative Care for Heart Failure and Co-Morbid Depression
Official Title
Blended Collaborative Care for Heart Failure and Co-Morbid Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Heart failure (HF) is an important public health problem that affects approximately 6.6 million Americans. Despite improvements in cardiac care, it remains the leading cause for hospitalization among Medicare patients and the only major cardiovascular disease whose mortality rate has remained essentially unchanged over the past decade. This failure to improve HF outcomes may be due, in part, to unrecognized and/or inadequately treated depression that is highly prevalent in HF patients. Yet while new HF treatment guidelines advocate routine screening for depression, this recommendation is unlikely to be widely adopted without trial evidence that depression care improves outcomes and efficient methods to provide it. "Collaborative care" strategies are being increasingly utilized to improve care for HF and other chronic medical conditions, and we recently demonstrated its clinical and cost-effectiveness at treating depression following coronary artery bypass graft surgery. Yet it may be impractical for health care delivery systems to support separate treatment programs for HF and depression. Thus we are encouraged by emerging evidence indicating "blended" collaborative care strategies that target both psychiatric and physical conditions produce greater improvements in mood symptoms and control of cardiovascular risk factors than programs focused solely on depression to propose testing a novel adaptation that could be provided in routine care. The Specific Aims of this Project are to: (1) evaluate the effectiveness of a telephone-delivered "blended" collaborative care intervention for treating HF and depression that could be adopted into routine clinical practice if proven effective; and (2) advance our understanding of the moderators and mediators of depression treatment on clinical outcomes. We will screen hospitalized patients with systolic HF for depression, and then randomize 625 who screen positive and have at least a moderately elevated level of depressive symptoms at two-weeks following hospital discharge to either: (1) collaborative care for treating both HF and depression ("blended"); (2) collaborative care for treating HF alone (enhanced usual care (eUC)); or (3) their doctors' "usual care" (UC). Additionally, we will enroll 125 non-depressed HF patients to better evaluate the benefits derived from treating depression (total N=750). Our co-primary hypotheses will test whether "blended" collaborative care can produce at 12-months follow-up a: (A) 0.50 effect size (ES) or greater improvement in health-related quality of life (HRQoL) vs. UC; and (B) 0.30 ES or greater improvement in HRQoL vs. eUC. Secondary hypotheses will evaluate the effects of our "blended" intervention on mood, functional status, adherence with guideline-consistent care, incidence of cardiovascular events, health care utilization, and costs. Improving chronic illness care for medically complex patients is one of the major challenges facing medicine today. We propose to test the effectiveness of an innovative, efficient, scalable, and sustainable intervention that could transform the way HF and other cardiovascular disorders are treated in routine practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Depression, Cardiovascular Disease
Keywords
Heart Failure, Systolic, Depressive Disorder, Depressive Disorder, Major, Mood Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
"Blended" intervention: Blended, centralized, nurse-provided, telephone-delivered collaborative care for both heart failure and depression; Collaborative care for heart failure: Blended, centralized, nurse-provided, telephone-delivered collaborative care for heart failure alone Usual Care: PCPs usual care for heart failure and depression; and Non-Depressed comparison cohort (randomly sampled, not randomized).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
756 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care for Heart Failure + Depression
Arm Type
Active Comparator
Arm Description
Collaborative 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
Arm Title
Collaborative Care for Heart Failure Only
Arm Type
Active Comparator
Arm Description
Collaborative 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
Arm Title
Usual Care for Heart Failure and Depression
Arm Type
No Intervention
Arm Description
Control group will receive their doctors' usual care for heart failure and depression
Arm Title
Non-Depressed Comparison Cohort
Arm Type
No Intervention
Arm Description
Control group will receive their doctors' usual care for heart failure
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care for Heart Failure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care for Depression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Description
Mental Health-Related Quality of Life
Time Frame
12-Months Follow-Up
Secondary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Description
Disease-Specific Health-Related Quality of Life
Time Frame
12-Month Follow-Up
Title
Hamilton Rating Scale for Depression (17-Item)
Description
Mood symptoms
Time Frame
12-Months Follow-Up
Title
Incidence of Rehospitalization
Time Frame
12-Month Follow-Up
Title
Mortality
Description
All-Cause and Cardiovascular Mortality
Time Frame
12-Month Follow-Up
Title
Health Care Costs
Description
Claims data
Time Frame
12-Month Follow-Up
Title
Employment
Time Frame
12-Months Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce L. Rollman, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27638965
Citation
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.
Results Reference
background
PubMed Identifier
26916974
Citation
Schuster 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.
Results Reference
background
PubMed Identifier
31083056
Citation
Herbeck 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.
Results Reference
background
PubMed Identifier
31151835
Citation
Rollman 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.
Results Reference
background
PubMed Identifier
34724453
Citation
Holber 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.
Results Reference
derived
PubMed Identifier
34459842
Citation
Rollman 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.
Results Reference
derived
Links:
URL
https://www.gim-crhc.pitt.edu/
Description
Center for Research on Health Care
URL
http://hopefulheart.pitt.edu/
Description
Related trial of collaborative care for treating depression following coronary artery bypass graft (CABG) surgery
URL
http://www.healthtech.pitt.edu/index.php
Description
Center for Behavioral Health and Smart Technology

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Blended Collaborative Care for Heart Failure and Co-Morbid Depression

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