Working… Menu

Evaluation of Web-based Transition Education to Enhance Transition Readiness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03303248
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):
Karen Uzark, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Transition Pediatric Congenital Heart Disease Behavioral: Web-based Educational Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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
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.

No Intervention: Standard of Care
This group will be given only the standard of care during their clinic visit.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03303248

Layout table for location contacts
Contact: Katherine Afton, BS 734-232-3945
Contact: Cynthia Smith, RN 734-615-0590

Layout table for location information
United States, Michigan
C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Research Coordinator   
Contact: Principal Investigator   
Sponsors and Collaborators
University of Michigan
Layout table for investigator information
Principal Investigator: Karen Uzark, PhD, CPNP University of Michigan

Layout table for additonal information
Responsible Party: Karen Uzark, Clinical Professor of Cardiac Surgery and Pediatric Cardiology, University of Michigan Identifier: NCT03303248     History of Changes
Other Study ID Numbers: HUM00130432
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities