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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: group-based skill building self-care program

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • NYU Langone Medical Center
    • New York, New York, United States, 10010
      • Bellevue Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	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	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	Changes in baseline health related quality of life at 3 month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Victoria Vaughan Dickson, PhD, RN, FAHA, NYU College of Nursing

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Self-Care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: R10-02126; 10CRP4140049 (Other Identifier: American Heart Association)