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Improving Quality of Life in Heart Failure

Primary Purpose

Heart Failure, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Treatment
Time Management
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem-Solving Treatment

Time Management

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 15, 2017
Last Updated
May 2, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03288194
Brief Title
Improving Quality of Life in Heart Failure
Official Title
Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
April 24, 2017 (Actual)
Study Completion Date
April 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Treatment
Arm Type
Experimental
Arm Description
Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.
Arm Title
Time Management
Arm Type
Active Comparator
Arm Description
Time Management is a structured, yet flexible, intervention intended to increase creativity.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Treatment
Intervention Type
Behavioral
Intervention Name(s)
Time Management
Primary Outcome Measure Information:
Title
Change in Kansas City Cardiomyopathy Questionnaire
Description
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.
Time Frame
1 month, 2 months, 3 months, 4 months, 5 months
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory
Description
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.
Time Frame
1 month, 2 months, 3 months, 4 months, 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A Shaffer, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improving Quality of Life in Heart Failure

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