Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBryan Heart

About this trial

There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and concern following a VAD implant as various time points. The investigators want to provide better patient care through increased education and awareness beyond surgical outcomes and contribute to patient understanding of "what to expect" following a VAD implant.

The investigators have created an anticipatory guidance (AG) tool based upon previous responses recorded in a local program's database, from the Quality of Life with a Left Ventricular Assist Device (QoLVAD) questionnaire. This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual/well-being). Investigators have previously analyzed responses to determine common areas of satisfaction and concern at 3-, 6-, 12- and 24-months post-VAD implant to better understand quality of life when living with a VAD. Investigators have had both VAD clinicians and VAD patients initially evaluate the tool to determine accuracy and effectiveness of the anticipatory guidance (AG) tool.

Eligibility criteria

Qualifiers

scheduled for a VAD implantation

English-speaking as the VAD AG Tool v5.0 has not yet been translated beyond English age ≥19 years at the time of implant as most states in North America have an age of majority for consent signing.

Disqualifiers

Not scheduled for VAD surgery

Non English speaking

<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

10 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Bryan Heart

Lead sponsor

International Consortium of Circulatory Assist Clinicians

Collaborator

International Society for Heart and Lung Transplantation

Collaborator