Improving Quality of Life in Heart Failure

Heart Failure Clinical Trial

Official title:

Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288194
• Other study ID #: 15-1619
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 24, 2017

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 24, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Quality of Life

Intervention

Behavioral:
• Problem-Solving Treatment

• Time Management

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Beck Depression Inventory	The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.	1 month, 2 months, 3 months, 4 months, 5 months