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

NCT05663320 | Withdrawn

• 2 other identifiers: 10000411000411-CC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Adrenal Hyperplasia

Keywords

Self-Paced; Interactive; Adrenal Biomarkers; Trxansition Index Score; Health Care Transition

Outcome Measures

Primary Outcomes (1)

• UNC Trxansition Index measure

  The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.

  12 months

Secondary Outcomes (6)

• Disease-specific knowledge

  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

  12 months

• HRQoL based on Short Form Health Survey (SF-36).

  12 months

• Number of hospitalizations per year related to CAH

  12 months

Study Arms (2)

1

OTHER

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

2

NO INTERVENTION

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

Interventions

virtual educational based transition intervention self-paced OTHER

study intervention is a standardized, virtual educational video on CAH that will be delivered self-paced

1

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ruth W Parker, C.R.N.P.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: December 23, 2022
• Study Start: December 9, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)