NCT01894750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 heart-failure

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1 heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4.3 years

First QC Date

July 1, 2013

Last Update Submit

April 14, 2015

Conditions

Heart Failure

Keywords

Heart FailureSelf-Care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in baseline Heart failure knowledge score at 1 month

    Change in baseline Heart failure knowledge score at 1 month

  • Change in baseline Heart failure knowledge score at 3 month

    Change in baseline Heart failure knowledge score at 3 month

Other Outcomes (2)

  • Changes in baseline Health related quality of life at 1 month

    Changes in baseline health related quality of life at 1 month

  • Changes in baseline Health related quality of life at 3 month

    Changes in baseline health related quality of life at 3 month

Study Arms (2)

skill bulding Intevention

EXPERIMENTAL

group-based skill building self-care program

Behavioral: group-based skill building self-care program

usual care

NO INTERVENTION

Interventions

group-based skill building self-care programBEHAVIORAL
skill bulding Intevention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of chronic HF
  • able to read and speak English or Spanish
  • over age 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hospital

New York, New York, 10010, United States

Location

NYU Langone Medical Center

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Victoria Vaughan Dickson, PhD, RN, FAHA

    NYU College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 10, 2013

Study Start

June 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(2)