Heart FailureCOPE-HFNCT00873418
Coping Skills and Heart Failure: Outcomes and Mechanisms
A study testing Coping skills training in people with Heart Failure, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Coping skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Coping Skills Training in Heart Failure: Outcomes and Mechanisms
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Coping skills training
- Keywords
- Heart Failure, Intervention, Cognitive Behavior Therapy, Quality of Life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping skills trainingBehavioural
Also called COPE-HF
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.
| Study group | Role | What they receive |
|---|---|---|
| Coping Skills Training | Experimental | 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. Receives: Behavioral: Coping skills training |
| Educational Control | Active comparator | 16 weekly telephone calls for extended (standardized) care on heart failure education. Receives: Behavioral: Coping skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Andrew Sherwood, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873418
- Sponsor's protocol ID
- Pro00009707
- Other IDs
- 1R01HL091920-01A1
- Acronym
- COPE-HF
- Status last verified
- Mar 2017
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30998063Sherwood 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.
PubMed 28062537Sherwood 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.
PubMed 21362527
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Skills Training in Heart Failure: Outcomes and Mechanisms
- ClinicalTrials.gov ID
- NCT00873418
- Acronym / sponsor ID
- COPE-HF / Pro00009707
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Intervention, Cognitive Behavior Therapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Skills Training | Experimental | Behavioral: Coping skills training16 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. |
| Educational Control | Active comparator | Behavioral: Coping skills training16 weekly telephone calls for extended (standardized) care on heart failure education. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping skills trainingAlso: COPE-HF16 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. | Behavioural | Coping Skills Training, Educational Control |
Primary outcome
Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes
Time frame: yearly
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Derived from this study: PubMed 30998063Blumenthal 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.
- Derived from this study: PubMed 28062537Sherwood 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.
- Derived from this study: PubMed 21362527Sherwood 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sherwood, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping skills training in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes (time frame: yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873418, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.