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Completed

NCT Number: NCT03288194

Improving Quality of Life in Heart Failure

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).

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Denver, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem-Solving Treatment

Behavioral

Time Management

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2017
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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