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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01894750
Enrollment
75
Registered
2013-07-10
Start date
2010-06-30
Completion date
2014-09-30
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Self-Care

Brief summary

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.

Interventions

BEHAVIORALgroup-based skill building self-care program

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in baseline heart failure self-care score at one monthChange from baseline heart failure self-care at 1 monthHeart 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.
Change in baseline heart failure self-care score at 3 monthsChange from baseline heart failure self-care at 3 monthsHeart 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

MeasureTime frameDescription
Change in baseline Heart failure knowledge score at 1 monthChange in baseline Heart failure knowledge score at 1 monthHeart 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.
Change in baseline Heart failure knowledge score at 3 monthChange in baseline Heart failure knowledge score at 3 monthHeart 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

MeasureTime frameDescription
Changes in baseline Health related quality of life at 1 monthChanges in baseline health related quality of life at 1 monthHealth 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
Changes in baseline Health related quality of life at 3 monthChanges in baseline health related quality of life at 3 monthHealth 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026