Improving Quality of Life in Heart Failure

NCT ID: NCT03288194

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-04-24

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.

Conditions

Heart Failure; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Problem-Solving Treatment

Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.

Group Type: EXPERIMENTAL

Problem-Solving Treatment

Intervention Type: BEHAVIORAL

Time Management

Time Management is a structured, yet flexible, intervention intended to increase creativity.

Group Type: ACTIVE_COMPARATOR

Time Management

Intervention Type: BEHAVIORAL

Interventions

Problem-Solving Treatment

Intervention Type: BEHAVIORAL

Time Management

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan A Shaffer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Denver, Colorado, United States

Countries

United States

Other Identifiers

15-1619

Identifier Type: -

Identifier Source: org_study_id