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Virtual Education Program for Congenital Adrenal Hyperplasia

N/A

Recruiting

Led By Ruth W Parker, C.R.N.P.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with CAH and enrolled in the Natural History Study Protocol 06-CH-0011

Patients between ages 16-22

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tests a virtual method to teach adolescents and young adults with CAH to care for themselves as they become adults.

Who is the study for?

This trial is for adolescents and young adults aged 16 to 22 with Congenital Adrenal Hyperplasia (CAH), who are already part of the Natural History Study Protocol 06-CH-0011. They must be able to understand English, have internet access, and commit to all study procedures for a year.Check my eligibility

What is being tested?

The study tests a virtual education program designed to help patients manage CAH as they transition from pediatric to adult care. Participants will either watch an educational video or receive standard education, with follow-ups at six and twelve months.See study design

What are the potential side effects?

Since this is an educational intervention rather than a medical treatment, there are no direct physical side effects expected. However, participants may experience varying levels of engagement or stress related to managing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have CAH and am part of the Natural History Study 06-CH-0011.

Select...

I am between 16 and 22 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

UNC Trxansition Index measure

Secondary outcome measures

Degree of disease control based on two commonly used adrenal biomarkers

Disease-specific knowledge

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

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 1Experimental Treatment1 Intervention

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.

Group II: 2Active Control1 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

880,982 Total Patients Enrolled

Ruth W Parker, C.R.N.P.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

Media Library

Virtual Education-Based Transition Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05663320 — N/A

Congenital Adrenal Hyperplasia Research Study Groups: 1, 2

Congenital Adrenal Hyperplasia Clinical Trial 2023: Virtual Education-Based Transition Intervention Highlights & Side Effects. Trial Name: NCT05663320 — N/A

Virtual Education-Based Transition Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05663320 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile compatible with participation in this research?

"Those who hope to gain admission into this research project need to have a diagnosis of congenital adrenal hyperplasia and be in between the ages of 16 and 22. In total, 20 participants are sought out for recruitment."

Answered by AI

Have recruitment opportunities for this experiment concluded?

"Data hosted on clinicaltrials.gov reveals that this study, which was inaugurated on June 20th 2023, is no longer accepting patients at the present time. However, there are currently 135 other medical trials recruiting enrollees."

Answered by AI