Understanding what to expect after getting a Ventricular Assist Device
Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
This study is trying to help patients understand what to expect after getting a Ventricular Assist Device for heart failure, so they can feel more at ease and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bryan Heart Academic / other |
| Locations | 2 sites (Lincoln, Nebraska and 1 other locations) |
| Trial ID | NCT06823583 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance patient education regarding the expectations and outcomes following the implantation of a Ventricular Assist Device (VAD) for advanced heart failure. By utilizing an anticipatory guidance tool developed from previous patient responses, the study seeks to identify common areas of satisfaction and concern at various time points post-implantation. The goal is to improve health-related quality of life and reduce anxiety and depression among patients by providing comprehensive information about their journey after receiving a VAD.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking adults aged 19 and older who are scheduled for VAD implantation.
Not a fit: Patients who are not scheduled for VAD surgery or are non-English speaking may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients by providing them with better understanding and expectations post-VAD implantation.
How similar studies have performed: While anticipatory guidance models are common in pediatric care, this approach for adults with chronic conditions like heart failure is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (For patient inclusion): * 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. (-VAD clinician for the clinician evaluation process) Exclusion Criteria: * Not scheduled for VAD surgery * Non English speaking * \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)
Where this trial is running
Lincoln, Nebraska and 1 other locations
- Bryan Heart — Lincoln, Nebraska, United States (Recruiting)
- Advocate Aurora Health — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma
- Email: sarah.schroeder@bryanheart.com
- Phone: 402-481-8450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.