NCT00873418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

5.9 years

First QC Date

March 30, 2009

Last Update Submit

March 29, 2017

Conditions

Heart Failure

Keywords

Heart FailureInterventionCognitive Behavior TherapyQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    yearly

Study Arms (2)

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.

Behavioral: Coping skills training

Educational Control

ACTIVE COMPARATOR

16 weekly telephone calls for extended (standardized) care on heart failure education.

Behavioral: Coping skills training

Interventions

Coping skills trainingBEHAVIORAL

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.

Also known as: COPE-HF
Coping Skills TrainingEducational Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • 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.

    PMID: 30998063DERIVED

  • 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.

    PMID: 28062537DERIVED

  • 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.

    PMID: 21362527DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andrew Sherwood, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

April 1, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)