Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure
Biobehavioral Intervention in Heart Failure
3 other identifiers
interventional
380
1 country
1
Brief Summary
The purpose of this study is to determine the effect of biofeedback-relaxation combined with cognitive behavioral therapy on clinical, physical and psychological outcomes in patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started Jul 2004
Longer than P75 for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 16, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 5, 2012
June 1, 2012
5.8 years
November 16, 2005
June 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Examination of the impact of biofeedback-relaxation training on HF patient outcomes.
Baseline, 3-, and 12-Months
Secondary Outcomes (6)
Perceived Control
Baseline, 3-, and 12-Months
Anxiety
Baseline, 3-, and 12-Months
Depression
Baseline, 3-, and 12-Months
Skin Temperature
Baseline, 3-, and 12-Months
Heart Rate Variability
Baseline, 3-, and 12-Months
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
NO INTERVENTIONUsual Care
Interventions
Eligibility Criteria
You may qualify if:
- confirmed diagnosis of chronic advanced HF. Other sample selection criteria include: 1) on stable doses of HF medication for at least one month; and 2) not referred for heart transplantation.
You may not qualify if:
- Patients will be excluded if they have: 1) valvular heart disease (as a primary cause of their HF; can have it if the primary cause is ischemic, hypertensive or idiopathic), peripartum heart failure, myocarditis; 2) history of cerebral vascular accident (CVA) within previous 3 months or major stroke sequelae; 3) history of major extremity vascular problems; 4) recent (within 3 months) myocardial infarction (MI); 5) coexisting terminal illness; 6) systolic blood pressure less than 80 mmHg; or 7) previous experience with biofeedback, relaxation .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40535, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Moser, DNSc, RN
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 16, 2005
First Posted
November 21, 2005
Study Start
July 1, 2004
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 5, 2012
Record last verified: 2012-06