Back to resultsBuilding Skill in Heart Failure Self-care: A Community Based Intervention
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
group-based skill building self-care program
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Self-Care
Eligibility Criteria
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
Sites / Locations
- Bellevue Hospital
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
skill bulding Intevention
usual care
Arm Description
group-based skill building self-care program
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01894750
Brief Title
Building Skill in Heart Failure Self-care: A Community Based Intervention
Official Title
Building Skill in Heart Failure Self-Care: A Community Based Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Self-Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
skill bulding Intevention
Arm Type
Experimental
Arm Description
group-based skill building self-care program
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
group-based skill building self-care program
Primary Outcome Measure Information:
Title
Change in baseline heart failure self-care score at one month
Description
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
Title
Change in baseline heart failure self-care score at 3 months
Description
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
Secondary Outcome Measure Information:
Title
Change in baseline Heart failure knowledge score at 1 month
Description
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
Title
Change in baseline Heart failure knowledge score at 3 month
Description
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
Other Pre-specified Outcome Measures:
Title
Changes in baseline Health related quality of life at 1 month
Description
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
Title
Changes in baseline Health related quality of life at 3 month
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Vaughan Dickson, PhD, RN, FAHA
Organizational Affiliation
NYU College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Building Skill in Heart Failure Self-care: A Community Based Intervention
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