Improving Quality of Life in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure; Quality of Life
• Interventions: Behavioral: Time Management; Behavioral: Problem-Solving Treatment

• Registration Number: NCT03288194
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2015-10
• Primary Completion: 2017-04-24
• Study Completion: 2017-04-24
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time Management	Time Management	Time Management is a structured, yet flexible, intervention intended to increase creativity.
Problem-Solving Treatment	Problem-Solving Treatment	Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.

Primary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire	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 Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory	1 month, 2 months, 3 months, 4 months, 5 months	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.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Denver, Colorado, United States