RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-10
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06823583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * scheduled for a VAD implantation
  2. * 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.
  1. * Not scheduled for VAD surgery
  2. * Non English speaking
  3. * \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Contacts and Locations

Study Contact

Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma
CONTACT
402-481-8450
sarah.schroeder@bryanheart.com
Kristin Sandau, PhD, RN
CONTACT
612-625-0186
KSandau@umn.edu

Principal Investigator

Mathue Baker, MD
STUDY_CHAIR
Bryan Heart

Study Locations (Sites)

Bryan Heart
Lincoln, Nebraska, 68506
United States

Collaborators and Investigators

Sponsor: Bryan Heart

  • Mathue Baker, MD, STUDY_CHAIR, Bryan Heart

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • expectations
  • VAD
  • Advanced Heart Failure
  • Anticipatory Guidance
  • quality of life

Additional Relevant MeSH Terms

  • Ventricular Assist Device
  • Advanced Heart Failure
  • Anticipatory Guidance