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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: group-based skill building self-care program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skill bulding Intevention<br>group-based skill building self-care program | Behavioral: group-based skill building self-care program<br> <br> |
| No Intervention: usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline heart failure self-care score at one 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. | Change from baseline heart failure self-care at 1 month | 
| Change in baseline heart failure self-care score 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. | Change from baseline heart failure self-care at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | Change in baseline Heart failure knowledge score at 1 month | 
| 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. | Change in baseline Heart failure knowledge score at 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Self-Care