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CompletedNCT03303248Updated Aug 26, 2025

Evaluation of Web-based Transition Education to Enhance Transition Readiness

An interventional study of Web-based Educational Intervention in Congenital Heart Disease, Transition and Pediatric Congenital Heart Disease, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by University of Michigan · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
13 Years to 25 Years
Sex
All
01

Study summary

The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.

02

Conditions studied

  • Congenital Heart Disease
  • Transition
  • Pediatric Congenital Heart Disease
03

Who can participate

Ages eligible
13 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with congenital heart disease
  • Ages 13-25
  • Routine outpatient cardiology follow-up visit

Exclusion criteria

Exclusion Criteria:

  • New patients to cardiology clinic
  • Patients being evaluated for an acute medical problem
  • Patients who do not speak English
  • Severe neurocognitive impairment that precludes ability to complete the questionnaire
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Web-based Educational Intervention

    This group of participants will be given access to a web-based educational resource in addition to the standard of care.

    Behavioral: Web-based Educational Intervention

  • No intervention
    Standard of Care

    This group will be given only the standard of care during their clinic visit.

Interventions

  • BehavioralWeb-based Educational Intervention

    A web-based educational tool, created for patients with congenital heart disease, will be given to patients using an ipad. This additional educational tool will be used with the standard of care visit with provider.

05

What researchers measure

Primary outcomes

  1. Change in transition readiness score, as measured by transition readiness survey

    The transition readiness survey is used to measure a participant's self-reported knowledge about their health and readiness to take charge of their healthcare. Each item is scored from 1 to 5, where 1 means "No, I do not know how" and 5 means "Yes, I always do this when I need to." The overall score is determined by calculating the sum of all questions on a 100 point scale. A higher score indicates greater readiness for transition.

    Time frame: baseline, 12 months

06

Study locations

1 site
  • C.S. Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
07

References and documents

Publications

  • Uzark K, Smith C, Donohue J, Yu S, Afton K, Norris M, Cotts T. Assessment of Transition Readiness in Adolescents and Young Adults with Heart Disease. J Pediatr. 2015 Dec;167(6):1233-8. doi: 10.1016/j.jpeds.2015.07.043. Epub 2015 Aug 19. PubMed 26298627 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03303248
Lead sponsor
University of Michigan
Collaborators
University of Nebraska
Responsible party
Karen Uzark (Clinical Professor of Cardiac Surgery and Pediatric Cardiology, University of Michigan) — Principal investigator
First posted
Oct 5, 2017
Start date
Aug 27, 2018
Primary completion
Jun 1, 2025
Completion
Jun 30, 2025
Last update
Aug 26, 2025

Study contacts

Karen Uzark, PhD, CPNP
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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