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
This trial does not accept healthy volunteersQualifiers
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 population
Advanced heart failure patients will be approached by their internal VAD teams who have been scheduled for a VAD implantation. Only age requirement is \>/= 19 as the age of majority in most states for consenting is 19. The goal is to consent consecutively so as to limit selection bias as much as able to. This is a feasibility study so consecutive approaching is key.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10 Participants
are grouped into 2 trial groupsGroup A: VAD Clinician Cohort
Group B: VAD Patient Cohort
Trial outcomes
Primary outcomes
1
Clinician perspectives
Evaluate clinician perspectives of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0 for accuracy, by completing an evaluation where each item will be scored 1-4, as follows: 1 Not Relevant, 2 Somewhat Relevant, 3 Quite Relevant, 4 Highly Relevant
Time frame
First two weeks of study initiation.Other outcomes
1
Distribution of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Each site investigator will validate that the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0 was preoperatively distributed.
Time frame
12 months2
Postoperative patient perceptions of Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Consented patients will provide prospectives of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0, through a patient evaluation form where all tool items will be scored on a 1-4 scale, where 1 is Not Important, 2 is Somewhat Important, 3 is Quite Important, 4 is Highly Important
Time frame
12 months3
Complete post-operative Quality of Life with a Left Ventricular Assist Device (QoLVAD)
All consented participants will complete the QoLVAD questionnaire at three time points (3-6-12 months)
Time frame
12 months4
Complete post-operative Generalized Anxiety Disorder 7-item scale at three different time points
All consented participants will complete the GAD-7 assessment at three time points (3-6-12 months)
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bryan Heart
Lead sponsor
International Consortium of Circulatory Assist Clinicians
Collaborator
International Society for Heart and Lung Transplantation
Collaborator
Source ClinicalTrials.gov