A Phase 1/2 interventional study of group-based skill building self-care program in Heart Failure, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by NYU Langone Health · Phase 1/2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
group-based skill building self-care program
Behavioral: group-based skill building self-care program
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.
Time frame: 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.
Time frame: Change from baseline heart failure self-care at 3 months
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.
Time frame: 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.
Time frame: Change in baseline Heart failure knowledge score at 3 month
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
Time frame: Changes in baseline health related quality of life at 1 month
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
Time frame: Changes in baseline health related quality of life at 3 month
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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NYU Langone Health