Improving Quality of Life in Heart Failure
Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
1 other identifier
interventional
14
1 country
1
Brief Summary
This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Oct 2015
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
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedMay 6, 2022
May 1, 2022
1.6 years
September 15, 2017
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
1 month, 2 months, 3 months, 4 months, 5 months
Secondary Outcomes (1)
Change in Beck Depression Inventory
1 month, 2 months, 3 months, 4 months, 5 months
Study Arms (2)
Problem-Solving Treatment
EXPERIMENTALProblem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.
Time Management
ACTIVE COMPARATORTime Management is a structured, yet flexible, intervention intended to increase creativity.
Interventions
Eligibility Criteria
You may qualify if:
- Outpatient
- Age \> 21
- Exhibits symptoms of hear failure (NYHA Class II or III)
- Left ventricular ejection fraction (LVEF) \>= 40%
- Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score \< 60
You may not qualify if:
- Cannot speak English
- Lack telephone access
- Unwilling to be randomized, or
- Unavailable for the study period
- Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
- Planned (within 6 months) cardiac surgery
- Cognitive impairment indicative of dementia
- Recent (3 months)
- acute myocardial infarction,
- cardiac decompensation, or
- HF-related hospitalization.
- Use intravenous inotropic medication
- Use an assistive circulatory device
- Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
- Currently receiving mental health counseling;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado
Denver, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan A Shaffer, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
October 1, 2015
Primary Completion
April 24, 2017
Study Completion
April 24, 2017
Last Updated
May 6, 2022
Record last verified: 2022-05