Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT07559253

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 12 - 26

Healthy Volunteers: Not accepted

Interventions

Accessible Care Model Visit

Recruitment Interviews

Participating Patient-Support Person Interviews

Participating Patient-Support Person Surveys

Participating Provider Interviews and surveys

Study Details

Brief 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.

Conditions

Congenital Heart Disease

Study ID

NCT07559253

Start date

Dec 1, 2025

Status verified date

Apr, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 26

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Patients

Diagnosed CHD patients between the ages of 12-26 years.

experimental: Patient Support People

experimental: Patient Health Care Providers

Interventions

Accessible Care Model Visit

Accessible care activities will be performed by the provider following the patient participants enrollment in the study and may be observed by study staff.

Recruitment Interviews

A subset of 3-10 patient participants (plus their health care providers) who consent to be reapproached will complete 30-60 minute recruitment interviews.

Participating Patient-Support Person Interviews

Patients, and their support person if present, may complete a 30-60 minute structured or unstructured interviews following the education session in a standard clinical encounter. Dyadic interviews will be analyzed 5 at a time over three phases of study until saturation.

Participating Patient-Support Person Surveys

Participants will complete a survey led by the study team member to identify factors hypothesized to affect transition including age, ethnicity, race, education, transportation, distance from home to clinic, other children at home, plans for care in the transition from pediatric to adult care.

Participating Provider Interviews and surveys

Before the end of each wave, a brief (15-20 minute) unstructured interview with the healthcare team will be conducted.

Unstructured and semi-structured interviews

Semi-structured interviewing is based on the use of an interview guide. Unstructured interviewing is used both as a form of primary data collection and to develop semi-structured interview or survey questions. It is particularly useful know about the lived experience of a participant. In this case, their experiences of transition education and of the clinical encounter.

Primary outcome measure

  • Percentage of Uptake of Assigned Components [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Catherine Allen, MD

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

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • healthcare
  • transition to adult care
  • improve care
  • pediatric
  • RE-AIM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-05.