A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia

December 9, 2025 updated by: National Institutes of Health Clinical Center (CC)

A Feasibility Pilot Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia.

Background:

Children with congenital adrenal hyperplasia (CAH) can survive well into adulthood with proper treatment. But the change from pediatric to adult care can be challenging. Many people with CAH need extra support as they learn to take control of their own health care needs. Researchers have studied how people respond to different types of patient education. Now researchers want to find out if virtual education, via computer, is a good way to teach people how to manage CAH as they become adults.

Objective:

To test a virtual method of delivering patient education to adolescents and young adults with CAH.

Eligibility:

Adolescents and young adults aged 16 to 22 years who have CAH. They must already be enrolled in Natural History Study Protocol 06-CH-0011.

Design:

Participants may take part in the study remotely; they may also come to the clinic. They will have 3 visits in 1 year.

Participants will complete questionnaires. Topics will include what they know about CAH; whether they remember to take their medications on their own; and whether they schedule their own appointments. They will be asked about their quality of life. They will be asked about their physical and emotional health.

All participants will be taught how to care for themselves. The participants will be divided into 2 groups. Some will watch an 11-minute video on CAH that focuses on their goals as they become adults. The others will receive standard education.

After 6 months, participants will receive CAH education again.

After 12 months, participants will repeat the questionnaires from their first visit.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study Description:

Health Care Transition (HCT) is defined as planned movement of chronically ill youth and young adults from a child to an adult model of care. HCT initiatives aim to facilitate the transition process and reduce commonly observed complications associated with poor transition such as decreased health literacy, poor treatment adherence, discontinuity of care and poor medical outcomes. The NIH Clinical Center is a unique environment where children with rare diseases such as Congenital Adrenal Hyperplasia (CAH) are often followed longitudinally into adulthood. Rare diseases are understudied and few studies have investigated effective ways of delivering HCT focused education to improve transition readiness. This is a pilot, randomized controlled trial that will assess the feasibility and preliminary efficacy of a virtual education-based transition intervention to improve transition readiness in adolescents and young adults with CAH. We hypothesize that the virtual education-based transition intervention will be feasible and participants in the intervention arm, will have better transition readiness score, disease outcomes and quality of life as compared to participants who received usual care.

Objectives:

Primary objective: To assess the feasibility of a virtual education based transition intervention in adolescents and young adults with CAH.

Secondary Objective: To assess preliminary effectiveness of a virtual education-based transition intervention on measures of transition readiness.

Endpoints:

Primary Endpoint: a) study participant compliance rate of >= 67% with virtual education-based transition intervention, and b) feasibility of collecting all study questionnaires from >=75% of participants at all time periods.

Secondary Endpoint: The change in baseline to 12 months in the University of North Carolina (UNC) Trxansition Index score.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated informed assent or consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Patients between ages 16-22
  • Diagnosed with CAH and enrolled in the Natural History Study Protocol 06-CH-0011.
  • Ability to speak and comprehend English as this is a pilot study and the study intervention education video is currently only in English and requires validation before translation into other languages
  • Access to a computer/mobile device and the internet.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Patients with significant medical or cognitive impairment(s) that may interfere with participating in trial.
  • Participants unable to participate in all aspects of this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Intervention Study Arm 1 participants will receive an approximately 11minute educational video on CAH that focuses on transitional goals (at baseline, 3 months, and 6 months. This will be done via a NIH approved webbased REDCap. Completion will be recorded.
Other: virtual educational based transition intervention self-paced
study intervention is a standardized, virtual educational video on CAH that will be delivered self-paced
No Intervention: 2
Usual care Study Arm 2 participants will have their usual six-month CAH follow up to coincide with study visits at 0, 6 and 12 months. During their visit, study participants will receive standard care that includes self-injection teaching and sick day rules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UNC Trxansition Index measure
Time Frame: 12 months
The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific knowledge
Time Frame: 12 months
Disease-specific knowledge
12 months
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Time Frame: 12 months
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
12 months
Degree of disease control based on two commonly used adrenal biomarkers
Time Frame: 12 months
Degree of disease control based on two commonly used adrenal biomarkers
12 months
HRQoL based on Short Form Health Survey (SF-36).
Time Frame: 12 months
HRQoL based on Short Form Health Survey (SF-36).
12 months
Number of hospitalizations per year related to CAH
Time Frame: 12 months
Number of hospitalizations per year related to CAH
12 months
Number of school/work absences per year related to CAH
Time Frame: 12 months
Number of school/work absences per year related to CAH
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Investigators

  • Principal Investigator: Ruth W Parker, C.R.N.P., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Actual)

December 9, 2025

Study Completion (Actual)

December 9, 2025

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000411
  • 000411-CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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