Status:
COMPLETED
Improving Quality of Life in Heart Failure
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Quality of Life
Eligibility:
All Genders
21-99 years
Phase:
NA
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).
Detailed Description
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- A history of:
- bipolar disorder,
- psychosis, or
- substance abuse/dependency
- Severe depressive symptoms or suicidality
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03288194
Start Date
October 1 2015
End Date
April 24 2017
Last Update
May 6 2022
Active Locations (1)
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1
University of Colorado
Denver, Colorado, United States, 80045