Congenital Heart DiseaseNCT03303248
Evaluation of Web-based Transition Education to Enhance Transition Readiness
A study testing Web-based Educational Intervention in people with Congenital Heart Disease and Transition, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Congenital Heart Disease, Transition, Pediatric Congenital Heart Disease
- What is being tested?
- Web-based Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with congenital heart disease
- Ages 13-25
- Routine outpatient cardiology follow-up visit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease
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.
- Being tested
- Web-based Educational Intervention
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Web-based Educational Intervention |
| Standard of Care | No intervention | This group will be given only the standard of care during their clinic visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start27 Aug 2018
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Principal investigator, Karen Uzark, University of Michigan
- Investigators
- Karen Uzark, PhD, CPNP, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303248
- Sponsor's protocol ID
- HUM00130432
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2017
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03303248
- Acronym / sponsor ID
- HUM00130432
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Educational Intervention | Experimental | Behavioral: Web-based Educational InterventionThis group of participants will be given access to a web-based educational resource in addition to the standard of care. |
| Standard of Care | No intervention | –This group will be given only the standard of care during their clinic visit. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with congenital heart disease
- Ages 13-25
- Routine outpatient cardiology follow-up visit
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Educational InterventionA 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. | Behavioural | Web-based Educational Intervention |
Primary outcome
Change in transition readiness score, as measured by transition readiness survey
Time frame: baseline, 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 26298627Uzark 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Uzark, PhD, CPNP principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Educational Intervention in people with Congenital Heart Disease and Transition, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transition readiness score, as measured by transition readiness survey (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.