Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in Kansas City Cardiomyopathy Questionnaire
Study Overview
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 programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.
With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Problem-Solving Treatment
Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.
Intervention: Problem-Solving Treatment (Behavioral)
Time Management
Time Management is a structured, yet flexible, intervention intended to increase creativity.
Intervention: Time Management (Behavioral)
Outcomes
Primary Outcomes
Change in Kansas City Cardiomyopathy Questionnaire
Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months
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.
Secondary Outcomes
- Change in Beck Depression Inventory(1 month, 2 months, 3 months, 4 months, 5 months)