What side effects are associated with this type of intervention?

The most common treatments for Congenital Adrenal Hyperplasia (CAH) include glucocorticoids and mineralocorticoids. Glucocorticoids, such as hydrocortisone, prednisone, or dexamethasone, can cause side effects like weight gain, high blood pressure, osteoporosis, and increased risk of infections. Mineralocorticoids, such as fludrocortisone, may lead to side effects including hypertension, edema, and electrolyte imbalances. These medications are crucial for managing CAH but require careful monitoring to mitigate potential adverse effects.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals or related drugs for the treatment of Congenital Adrenal Hyperplasia (CAH). Generally, CAH is treated with glucocorticoids to replace deficient cortisol and mineralocorticoids if aldosterone is also deficient. The study mentioned focuses on virtual education to improve transition readiness in adolescents and young adults with CAH, aiming to help them manage their condition as they move from pediatric to adult care.

What other types of research exist?

Promising, novel alternatives to virtual education for CAH patients in 2024 include personalized mobile health applications, augmented reality (AR) for interactive learning, telehealth consultations, and peer support networks.

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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

Must not have

Participants unable to participate in all aspects of this clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if online lessons can help young people with CAH learn to manage their health as they transition to adult care. It aims to improve their knowledge, medication adherence, and appointment scheduling.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to participate in all parts of this clinical trial.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

UNC Trxansition Index measure

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Congenital Adrenal Hyperplasia (CAH) involves glucocorticoid therapy, which replaces the deficient cortisol, thereby reducing the overproduction of adrenocorticotropic hormone (ACTH) and excessive androgen production. This treatment is crucial for managing symptoms like abnormal growth and preventing adrenal crises. The virtual education being studied aims to enhance patients' understanding and management of their condition, which is vital for adherence to treatment and improving health outcomes.