Coping Skills and Heart Failure: Outcomes and Mechanisms (COPE-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping skills training
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Intervention, Cognitive Behavior Therapy, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Men or women aged 21 years or older
- New York Heart Association (NYHA) Class I-IV HF of at least 3-months duration
- Left ventricular Ejection Fraction (EF) < 40% by left ventricular angiography, nuclear wall motion study, or echocardiography, within 6 months of study enrollment
- Undergoing treatment with a stable medication regimen.
Exclusion Criteria:
- Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 months of enrollment
- HF due to correctable cause or condition such as uncorrected primary valvular disease
- Alcohol or drug abuse within 12 months
- Illness such as malignancies that are associated with a life-expectancy of < 12 months
- Current pregnancy
- Inability to provide informed consent
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coping Skills Training
Educational Control
Arm Description
16 week telephone intervention using coping skills training to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
16 weekly telephone calls for extended (standardized) care on heart failure education.
Outcomes
Primary Outcome Measures
Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes
The primary outcomes were: i) post intervention effects on HF disease biomarkers and QoL (both with alpha=0.01), and; ii) a composite measure of time to death or first hospitalization (with alpha=0.03) over a median follow-up period of 3 years.
Secondary Outcome Measures
Full Information
NCT ID
NCT00873418
First Posted
March 30, 2009
Last Updated
March 29, 2017
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00873418
Brief Title
Coping Skills and Heart Failure: Outcomes and Mechanisms
Acronym
COPE-HF
Official Title
Coping Skills Training in Heart Failure: Outcomes and Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate whether heart failure patients receiving a 16 week telephone delivered, intervention using cognitive behavior therapy to facilitate self-management of heart failure will have better clinical outcomes than heart failure patients receiving a 16 week heart failure education intervention via telephone.
Detailed Description
Over 5 million Americans suffer from heart failure (HF), with an associated annual health care cost in excess of $33 billion. With 500,000 new cases developing each year, HF is the only major cardiovascular disease that is increasing in prevalence. Despite intensive medical therapy, symptom instability and clinical deterioration are common and lead to frequent physician visits, hospitalization, and ultimately death. HF symptoms, including dyspnea and fatigue, are a major source of distress for patients with HF, and often impose severe limitations on their daily activities. Depression also is common in HF patients, and its presence is associated with increased risk of hospitalization and mortality, independent of disease severity. There is growing evidence that behavioral management is a critical component of living with HF that can reduce hospitalizations and help optimize health status. Although previous studies have demonstrated that case-management programs are effective, benefits appear to be short-lived once ongoing care is reduced. Prior research from our laboratory and others has shown that coping skills training (CST), designed both to teach patients self-management skills and to cope more effectively with psychological distress associated with their medical condition, is effective for such chronic diseases as diabetes, ischemic heart disease, and lung disease. However, CST has not yet been evaluated as an intervention to facilitate self-management of HF. We propose a randomized clinical trial comparing a 16-week CST intervention with Extended (Standardized) Care in a study sample of 200 HF outpatients, who are receiving medical treatment for HF according to current clinical practice guidelines. The CST intervention, delivered over the telephone, is designed reduce stress and depression and to improve aspects of health behavior that are related to HF outcomes, including symptom monitoring, medication adherence, dietary compliance, and physical activity. Before and following treatment, patients will be carefully assessed on important intermediate medical endpoints including HF disease biomarkers (B-type natriuretic peptide, ejection fraction, vascular endothelial function, autonomic regulation, and inflammatory activity), as well as on quality of life (QoL) indicated by both physical and psychosocial functioning. Effects of CST on clinical outcomes will be evaluated according to all-cause hospitalizations or mortality over a median follow-up period of 3 years. The data generated by the proposed study will provide important insights regarding the value of CST over and above usual medical care. If successful, we believe that the study findings should translate into initial recommendations for the incorporation of CST into self-management behavioral interventions as cost-effective approaches to enhance disease management, QoL and longevity in HF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Intervention, Cognitive Behavior Therapy, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coping Skills Training
Arm Type
Experimental
Arm Description
16 week telephone intervention using coping skills training to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
Arm Title
Educational Control
Arm Type
Active Comparator
Arm Description
16 weekly telephone calls for extended (standardized) care on heart failure education.
Intervention Type
Behavioral
Intervention Name(s)
Coping skills training
Other Intervention Name(s)
COPE-HF
Intervention Description
16 weekly telephone session using to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
Primary Outcome Measure Information:
Title
Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes
Description
The primary outcomes were: i) post intervention effects on HF disease biomarkers and QoL (both with alpha=0.01), and; ii) a composite measure of time to death or first hospitalization (with alpha=0.03) over a median follow-up period of 3 years.
Time Frame
yearly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women aged 21 years or older
New York Heart Association (NYHA) Class I-IV HF of at least 3-months duration
Left ventricular Ejection Fraction (EF) < 40% by left ventricular angiography, nuclear wall motion study, or echocardiography, within 6 months of study enrollment
Undergoing treatment with a stable medication regimen.
Exclusion Criteria:
Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 months of enrollment
HF due to correctable cause or condition such as uncorrected primary valvular disease
Alcohol or drug abuse within 12 months
Illness such as malignancies that are associated with a life-expectancy of < 12 months
Current pregnancy
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30998063
Citation
Blumenthal JA, Zhu Y, Koch GG, Smith PJ, Watkins LL, Hinderliter AL, Hoffman BM, Rogers JG, Chang PP, O'Connor C, Johnson KS, Sherwood A. The modifying effects of social support on psychological outcomes in patients with heart failure. Health Psychol. 2019 Jun;38(6):502-508. doi: 10.1037/hea0000716. Epub 2019 Apr 18.
Results Reference
derived
PubMed Identifier
28062537
Citation
Sherwood A, Blumenthal JA, Koch GG, Hoffman BM, Watkins LL, Smith PJ, O'Connor CM, Adams KF Jr, Rogers JG, Sueta C, Chang PP, Johnson KS, Schwartz J, Hinderliter AL. Effects of Coping Skills Training on Quality of Life, Disease Biomarkers, and Clinical Outcomes in Patients With Heart Failure: A Randomized Clinical Trial. Circ Heart Fail. 2017 Jan;10(1):e003410. doi: 10.1161/CIRCHEARTFAILURE.116.003410.
Results Reference
derived
PubMed Identifier
21362527
Citation
Sherwood A, O'Connor CM, Routledge FS, Hinderliter AL, Watkins LL, Babyak MA, Koch GG, Adams KF Jr, Dupree CS, Chang PP, Hoffman BM, Johnson J, Bowers M, Johnson KS, Blumenthal JA. Coping effectively with heart failure (COPE-HF): design and rationale of a telephone-based coping skills intervention. J Card Fail. 2011 Mar;17(3):201-7. doi: 10.1016/j.cardfail.2010.11.001. Epub 2011 Jan 21.
Results Reference
derived
Learn more about this trial
Coping Skills and Heart Failure: Outcomes and Mechanisms
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