Ignite Creation Date:
2024-05-05 @ 9:23 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00873418
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2009-03-30
Brief Title:
Coping Skills and Heart Failure Outcomes and Mechanisms
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Coping Skills Training in Heart Failure Outcomes and Mechanisms
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE-HF
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 500000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL091920-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HL091920-01A1 |