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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 22
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Ruth W Parker, C.R.N.P.
ruth.parker@nih.gov
(301) 496-8533
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
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.
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
Sponsors
Leads: National Institutes of Health Clinical Center (CC)

This content was sourced from clinicaltrials.gov