Clinical trial NCT01894750: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Keywords: Heart Failure
Self-Care
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in baseline heart failure self-care score at one month
timeFrame: Change from baseline heart failure self-care at 1 month
measure: Change in baseline heart failure self-care score at 3 months
timeFrame: Change from baseline heart failure self-care at 3 months
Secondary outcomes:
measure: Change in baseline Heart failure knowledge score at 1 month
timeFrame: Change in baseline Heart failure knowledge score at 1 month
measure: Change in baseline Heart failure knowledge score at 3 month
timeFrame: Change in baseline Heart failure knowledge score at 3 month
Other outcomes:
measure: Changes in baseline Health related quality of life at 1 month
timeFrame: Changes in baseline health related quality of life at 1 month
measure: Changes in baseline Health related quality of life at 3 month
timeFrame: Changes in baseline health related quality of life at 3 month
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU College of Nursing
name: Victoria Vaughan Dickson, PhD, RN, FAHA
role: PRINCIPAL_INVESTIGATOR
References: