NCT00178009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

February 18, 2011

Conditions

Congestive Heart Failure

Keywords

computer-assisted instructioninstruction (video)

Outcome Measures

Primary Outcomes (1)

  • Patient and caregiver competency scores

    Upon discharge

Secondary Outcomes (1)

  • Time and number of trials to competency for patients and caregivers.

    Upon discharge

Interventions

self-paced instructionBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Margo B. Holm, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

US(1)