Congenital Adrenal HyperplasiaNCT05663320
A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia
A study testing virtual educational based transition intervention self-paced in people with Congenital Adrenal Hyperplasia, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- virtual educational based transition intervention self-paced
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- virtual educational based transition intervention self-paced
- Keywords
- Self-Paced, Interactive, Adrenal Biomarkers, Trxansition Index Score, Health Care Transition
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual educational based transition intervention self-pacedOther
study intervention is a standardized, virtual educational video on CAH that will be delivered self-paced
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
UNC Trxansition Index measure
The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.
Measured: 12 months
Secondary outcomes (6)
Disease-specific knowledge
Disease-specific knowledge
Measured: 12 months
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Measured: 12 months
Degree of disease control based on two commonly used adrenal biomarkers
Degree of disease control based on two commonly used adrenal biomarkers
Measured: 12 months
HRQoL based on Short Form Health Survey (SF-36).
HRQoL based on Short Form Health Survey (SF-36).
Measured: 12 months
Number of hospitalizations per year related to CAH
Number of hospitalizations per year related to CAH
Measured: 12 months
Number of school/work absences per year related to CAH
Number of school/work absences per year related to CAH
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start9 Dec 2025
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Why it stopped: Study never opened; deemed duplicative of another active NIH protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ruth W Parker, C.R.N.P., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663320
- Sponsor's protocol ID
- 10000411
- Other IDs
- 000411-CC
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Pilot Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia.
- ClinicalTrials.gov ID
- NCT05663320
- Acronym / sponsor ID
- 10000411
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Self-Paced, Interactive, Adrenal Biomarkers, Trxansition Index Score, Health Care Transition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never opened; deemed duplicative of another active NIH protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: virtual educational based transition intervention self-pacedIntervention 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. |
| 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 |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual educational based transition intervention self-pacedstudy intervention is a standardized, virtual educational video on CAH that will be delivered self-paced | Other | 1 |
Primary outcome
UNC Trxansition Index measure
Time frame: 12 months
The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.
6 secondary outcomes
Disease-specific knowledge
Time frame: 12 months
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Time frame: 12 months
Degree of disease control based on two commonly used adrenal biomarkers
Time frame: 12 months
HRQoL based on Short Form Health Survey (SF-36).
Time frame: 12 months
Number of hospitalizations per year related to CAH
Time frame: 12 months
Number of school/work absences per year related to CAH
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth W Parker, C.R.N.P. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual educational based transition intervention self-paced in people with Congenital Adrenal Hyperplasia, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UNC Trxansition Index measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.