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Evaluation of Web-based Transition Education to Enhance Transition Readiness

Primary Purpose

Congenital Heart Disease, Transition, Pediatric Congenital Heart Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Web-based Educational Intervention

About this trial

This is an interventional other trial for Congenital Heart Disease

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

C.S. Mott Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web-based Educational Intervention

Standard of Care

Arm Description

This group of participants will be given access to a web-based educational resource in addition to the standard of care.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03303248

First Posted

October 2, 2017

Last Updated

September 20, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03303248

Brief Title

Evaluation of Web-based Transition Education to Enhance Transition Readiness

Official Title

Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 27, 2018 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease, Transition, Pediatric Congenital Heart Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Web-based Educational Intervention

Arm Type

Experimental

Arm Description

This group of participants will be given access to a web-based educational resource in addition to the standard of care.

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Web-based Educational Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in transition readiness score, as measured by transition readiness survey

Description

Time Frame

baseline, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katherine Afton, BS

Phone

734-232-3945

kafton@umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Cynthia Smith, RN

Phone

734-615-0590

csmithw@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Uzark, PhD, CPNP

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

C.S. Mott Children's Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Research Coordinator

kafton@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Principal Investigator

karenu@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26298627

Citation

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.

Results Reference

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Evaluation of Web-based Transition Education to Enhance Transition Readiness

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