Developing and Assessing Competencies for Caregivers and Patients With Ventricular Assist Devices

This study has been completed.
Sponsor:
Collaborator:
Beckwith Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178009
First received: September 13, 2005
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their status does not require hospitalization. This project includes development of CD/video and web-based instructional programs on management of the VAD controller for patients and their caregivers (formal and informal). A clinical trial will be used to examine discharge rates and placements following patients educated under usual care vs. self-pace CD/video conditions.


Condition Intervention
Congestive Heart Failure
Behavioral: self-paced instruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Developing and Assessing Competencies for Patients, Caregivers and Health Professionals for the Care of Patients Implanted With Ventricular Assist Devices

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Patient and caregiver competency scores [ Time Frame: Upon discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time and number of trials to competency for patients and caregivers. [ Time Frame: Upon discharge ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: self-paced instruction
    Patients and caregivers review a DVD as often as they wish on how to care for routine and emergency procedures associated with their artificial heart
Detailed Description:

Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). The current study is designed to develop an Artificial Heart Continuity of Care Competency Program (AHC3P) to ensure the safety and feasibility of their return to the community. This program will identify and delineate the step-by-step procedures required to care for a patient's ventricular assist device (VAD) on a daily basis, or during an emergency. These step-by-step procedures will be will be used to develop a self-paced learning CD/video program for patients and caregivers and competencies. The same competencies will also be used by the Artificial Heart Program team to assess caregiver skills, and provide direct feedback on steps that need revision or more in-depth instruction. Subjects will be recruited in four phases. Training for all four phases will be conducted by members of the AHP team. During Phase I, VAD recipients will be videotaped while undergoing the current Artificial Heart Program (AHP) training. During Phase II, VAD recipients and their caregivers will be recruited as the control group and will also undergo the current AHP training. Phase III will involve patients and their informal caregivers undergoing the AHC3P and will serve as the experimental group. Data regarding the self-efficacy of the trainees and the length of time and the number of trials required to achieve competency with the AHC3P will be compared to the training program currently in place. During the fourth phase, health care professionals from UPMC will be recruited to undergo the AHC3P training. Data regarding their self-efficacy prior to and after the training program will be compared.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Four males; 4 females. Mean age of 39.6 (age range = 26-67) Caucasian = 100%

Criteria

Inclusion Criteria:

Patient and Caregiver Phase: The inclusion criteria are: (1) patients implanted with a VAD and identified by a member of the AHP team to undergo training prior to discharge (2) informal caregiver of a patient implanted with a VAD and identified by a member of the AHP team to undergo training (3) are between 18 to 95 years of age. No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.

Health Professional Phase: The inclusion criteria are: (1) A licensed health-care professional (2) currently employed at UPMC No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.

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Exclusion Criteria:

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00178009

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Beckwith Foundation
Investigators
Principal Investigator: Margo B. Holm, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Margo B Holm, PhD, OTR/L, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178009     History of Changes
Other Study ID Numbers: 0403075
Study First Received: September 13, 2005
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
computer-assisted instruction
instruction (video)

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014