Evaluation of Web-based Transition Education to Enhance Transition Readiness

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Congenital Heart Disease; Pediatric Congenital Heart Disease; Transition
• Intervention / Treatment: Behavioral: Web-based Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Afton, BS; Phone Number: 734-232-3945; Email: kafton@umich.edu
• Study Contact Backup: Name: Cynthia Smith, RN; Phone Number: 734-615-0590; Email: csmithw@umich.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of Nebraska
• Investigators: Principal Investigator: Karen Uzark, PhD, CPNP, University of Michigan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: HUM00130432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No