RecruitingNot Applicable

Implementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework

United States450 participantsStarted 2025-12-01

Plain-language summary

The study includes patients with congenital heart disease (CHD), as well as their support persons and their providers, who are preparing to make the transition from pediatric to adult care for their CHD. The purpose of this study is to improve the tools available to help find doctors as patients enter adulthood. 200 people with CHD and support people will be enrolled.

Who can participate

Age range

12 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Patient Participants): * Diagnosed CHD patients between the ages of 12-26 will be eligible * Able to provide assent when seen by a pediatric or adult congenital cardiologist provider. * A subset of patients will self-identify as having a disability, and or, be identified with disabilities in their medical or educational records. * Participants to provide assent/consent and complete all study activities in English or Spanish * Participants under the age of 18 must have a legal guardian who is able to provide consent in English or Spanish. Exclusion Criteria: * Providers may decline participation of any patient at their clinical discretion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Uptake of Assigned Components

Timeframe: up to 1 year

Trial details

NCT IDNCT07559253

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Catherine Allen, MD

(608) 263-9783 ccallen@pediatrics.wisc.edu

View on ClinicalTrials.gov More Congenital Heart Disease trials