Improving Quality of Life in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03288194
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Heart Failure Quality of Life Behavioral: Problem-Solving Treatment Behavioral: Time Management Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
Actual Study Start Date : October 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Primary Outcome Measures :
  1. Change in Kansas City Cardiomyopathy Questionnaire [ Time Frame: 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 :
  1. Change in Beck Depression Inventory [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03288194

Contact: Jonathan A Shaffer, PhD 303-315-7053

United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Jonathan A Shaffer, PhD    303-556-2312   
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Jonathan A Shaffer, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT03288194     History of Changes
Other Study ID Numbers: 15-1619
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases