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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03303248
Other study ID # HUM00130432
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 27, 2018
Est. completion date December 30, 2024

Study information

Verified date April 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 25 Years
Eligibility Inclusion Criteria: - Diagnosed with congenital heart disease - Ages 13-25 - Routine outpatient cardiology follow-up visit 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Web-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.

Locations

Country Name City State
United States C.S. Mott Children's Hospital Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan University of Nebraska

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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