Skip to main content
OpenTrials
Completed

NCT Number: NCT01894750

Building Skill in Heart Failure Self-care: A Community Based Intervention

The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:

Hypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.

Hypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.

Hypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.

A secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bellevue Hospital, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of chronic HF
  • able to read and speak English or Spanish
  • over age 50

Exclusion criteria

  • history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia
  • unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).
  • living in a nursing home or other long term care facility

Treatment and study plan

group-based skill building self-care program

Behavioral

Primary outcomes

  1. Change in baseline heart failure self-care score at one month

    Time frame: Change from baseline heart failure self-care at 1 month

    Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline at one month will be assessed.

  2. Change in baseline heart failure self-care score at 3 months

    Time frame: Change from baseline heart failure self-care at 3 months

    Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline to 3 months will be assessed.

Secondary outcomes

  1. Change in baseline Heart failure knowledge score at 1 month

    Time frame: Change in baseline Heart failure knowledge score at 1 month

    Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total score from baseline at 1 month will be assessed.

  2. Change in baseline Heart failure knowledge score at 3 month

    Time frame: Change in baseline Heart failure knowledge score at 3 month

    Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total heart failure knowledge score from baseline to 3 months will be assessed.

Other outcomes

  1. Changes in baseline Health related quality of life at 1 month

    Time frame: Changes in baseline health related quality of life at 1 month

    Health related quality of life will be measured using valid and reliable Kansas City Cardiomyopathy Questionnaire. Changes in scores will be assessed from baseline to 3 months

  2. Changes in baseline Health related quality of life at 3 month

    Time frame: Changes in baseline health related quality of life at 3 month

    Health related quality of life will be measured using valid and reliable Kansas City Cardiomyopathy Questionnaire. Changes in scores will be assessed from baseline to 3 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Apr 15, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.