Improving Quality of Life in Heart Failure

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Quality of Life
• Intervention / Treatment: Behavioral: Problem-Solving Treatment; Behavioral: Time Management

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Problem-Solving Treatment; Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.	Behavioral: Problem-Solving Treatment
ACTIVE_COMPARATOR: Time Management; Time Management is a structured, yet flexible, intervention intended to increase creativity.	Behavioral: Time Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jonathan A Shaffer, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): April 24, 2017
• Study Completion (ACTUAL): April 24, 2017

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (ACTUAL): September 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 15-1619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No