NCT03303248

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

August 27, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

6.8 years

First QC Date

October 2, 2017

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

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.

    baseline, 12 months

Study Arms (2)

Web-based Educational Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

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.

Web-based Educational Intervention

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 26298627BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Karen Uzark, PhD, CPNP

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Cardiac Surgery and Pediatric Cardiology

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

August 27, 2018

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations