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

NCT ID: NCT01894750

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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skill bulding Intevention

group-based skill building self-care program

Group Type EXPERIMENTAL

group-based skill building self-care program

Intervention Type BEHAVIORAL

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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group-based skill building self-care program

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Vaughan Dickson, PhD, RN, FAHA

Role: PRINCIPAL_INVESTIGATOR

NYU College of Nursing

Locations

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Bellevue Hospital

New York, New York, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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10CRP4140049

Identifier Type: OTHER

Identifier Source: secondary_id

R10-02126

Identifier Type: -

Identifier Source: org_study_id

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