Improving Quality of Life in Heart Failure
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - 99 |
Updated: | 1/17/2019 |
Start Date: | October 2015 |
End Date: | April 2019 |
Contact: | Jonathan A Shaffer, PhD |
Email: | jonathan.shaffer@ucdenver.edu |
Phone: | 303-315-7053 |
Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
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).
Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with
stable heart failure (HF).
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.
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.
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
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