Virtual Education Program for Congenital Adrenal Hyperplasia

Overseen by Ruth W Parker, C.R.N.P.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Significant medical, cognitive impairments, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the Virtual Education Program for Congenital Adrenal Hyperplasia treatment?

Research on transition programs for chronic illnesses shows that having structured education and support during the transition to adult care can improve patients' ability to manage their health and increase satisfaction with care. Similar programs for conditions like ADHD have shown improved transition competence, suggesting that virtual education could be beneficial for patients with Congenital Adrenal Hyperplasia as well. ^{1 2 3 4 5}

Is the Virtual Education Program for Congenital Adrenal Hyperplasia safe for humans?

The research articles provided do not contain specific safety data for the Virtual Education Program for Congenital Adrenal Hyperplasia or similar virtual education programs. They focus on the transition to virtual formats in various medical education contexts during the COVID-19 pandemic, but do not address safety concerns related to these programs. ^{6 7 8 9 10}

How is the Virtual Education Program for Congenital Adrenal Hyperplasia different from other treatments?

The Virtual Education Program for Congenital Adrenal Hyperplasia is unique because it focuses on educating adolescents to manage their own health as they transition from pediatric to adult care, rather than directly treating the condition itself. This approach is designed to empower patients with knowledge and skills for self-management, which is different from traditional medical treatments that focus on medication or direct medical intervention. ^{2 4 5 11 12}

Research Team

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

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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.

Inclusion Criteria

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

I am willing and able to follow the study's procedures and be available for its duration.

Exclusion Criteria

I do not have any health or thinking problems that would stop me from joining the trial.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Education

Participants receive an 11-minute educational video on CAH focusing on transitional goals

1 day

1 visit (virtual)

Follow-up Education

Participants receive CAH education again at 6 months

1 day

1 visit (virtual)

Final Assessment

Participants repeat the questionnaires from their first visit to assess transition readiness and other outcomes

1 day

1 visit (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

Treatment Details

Interventions

• Virtual Education-Based Transition Intervention (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: 1 Experimental Treatment 1 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: 2 Active Control 1 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 Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Pius Aiyelawo

National Institutes of Health Clinical Center (CC)

Chief Executive Officer

MPA, FACHE

Dr. Karen Frank

National Institutes of Health Clinical Center (CC)

Chief Medical Officer

MD

Findings from Research

This study focuses on improving transitional care for young females with Mayer-Rokitansky-Kuester-Hauser Syndrome, involving 25 patients and 24 caregivers to identify care deficits and needs during their transition to adulthood.

The research aims to create a structured model for transitional care, validated by feedback from 100 participants, which could serve as a framework for future interventions in managing orphan diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a provisional model to improve transitional care for female adolescents with a rare genital malformation as an example for orphan diseases. Simoes, E., Kronenthaler, A., Emrich, C., et al.[2018]

The study involved interviews with 18 health professionals to understand their perspectives on adolescent transition programs for chronic illness management, revealing a fragmented understanding of program goals among staff.

Time constraints and the need for more resources, such as staff and space, were identified as significant barriers to effectively implementing these programs, highlighting the need for a unified approach and better support for health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I can't pose a whole heap of questions that I know I don't have time to follow up"-Exploring perceptions of an adolescent transition program. Fløtten, KJØ., Aujoulat, I., Wyller, VBB., et al.[2023]

Transition coordinators can significantly improve the transfer of youth with chronic illnesses to adult care by meeting with patients before the transfer, supporting them during the transition, and helping them keep appointments.

Establishing trusting relationships with adult providers and having discussions about the transition process with both pediatric and adult providers are crucial for successful care transfer, highlighting the importance of planning and communication in these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Interventions Aimed at Facilitating Successful Transition Planning and Transfer to Adult Care Among Youth with Chronic Illness. Weissberg-Benchell, J., Shapiro, JB.[2017]

A transition workshop for 56 adolescents and young adults with ADHD significantly improved their transition competence compared to a control group, indicating that structured education can help in managing the shift from child to adult care.

Participants in the workshop reported high satisfaction with the program, although there was no significant change in patient activation levels, suggesting that while the workshop was effective for transition skills, it may not directly enhance overall engagement in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transition-oriented patient education program for adolescents and young adults with ADHD]. Schmidt, H., Heidemann, LS., Menrath, I., et al.[2023]

Effective transition from pediatric to adult healthcare for young people with chronic illnesses is crucial to prevent adverse health consequences, and this can be achieved through structured programs like the one from the Royal Children's Hospital in Melbourne.

Key strategies for successful transition include fostering independence in young patients, ensuring comprehensive health information transfer, and promoting joint clinics between pediatric and adult healthcare teams to enhance continuity of care and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young people with chronic illness: the approach to transition. Kennedy, A., Sloman, F., Douglass, JA., et al.[2022]

The transition to virtual training for intrauterine contraception during the COVID-19 pandemic allowed healthcare providers to continue their education without needing to travel, using online materials and livestreamed sessions.

Participants in the virtual training reported a high level of skill acquisition and positive impacts on their clinical practice, indicating that this method is effective for teaching essential clinical skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Skills Training Format for Teaching Intrauterine Contraception Insertion During Coronavirus Disease 2019. Metcalf-Wilson, K., Bates, A., Webb, S., et al.[2022]

A virtual learning platform effectively engaged 58 third-year medical students during COVID-19, allowing them to continue their surgical education through online modules and coaching focused on core entrustable professional activities (EPAs).

The program resulted in high student engagement with 100% attendance and demonstrated progressive proficiency in skills, indicating that virtual learning can successfully supplement traditional clinical training, especially when students have prior hands-on experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Homeschooling Surgery Students: Washington State University's Longitudinal Integrated Clerkship Transitioned to a Hybrid-Virtual Platform Triggered by the COVID-19 Pandemic. Kumar, AS.[2022]

40% of allied health education institutions surveyed are currently using virtual learning environments to enhance skill development.

The study highlights the potential benefits of adopting virtual learning technology in allied health education, drawing on successful applications in other healthcare professions like medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of virtual learning environments in the allied health professions. Butina, M., Brooks, D., Dominguez, PJ., et al.[2015]

A quality improvement project at two academic hospitals successfully implemented a virtual insulin teaching program for hospitalized diabetes patients, reducing the mean time from referral to successful teaching by 0.27 days during the COVID-19 pandemic.

Despite the improvements, the virtual teaching model was found to be less efficient than traditional in-person methods, highlighting the need for ongoing enhancements in virtual care delivery for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of virtual insulin teaching for patients admitted to hospital through the COVID-19 pandemic: a quality improvement initiative. Tong, J., Meehan, R., Iannicello, D., et al.[2023]

In a study of 118 young adults with pediatric onset heart disease, 79% successfully transferred to adult cardiology care when advised, highlighting the importance of proper guidance during the transition.

Key factors associated with successful transfer included having had prior cardiac surgery, being on cardiac medications, and having follow-up appointments within a year, indicating that these elements may enhance the likelihood of effective transition to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of Transition Education and Referral Patterns from Pediatric Cardiology to Adult Cardiac Care. Harbison, AL., Grady, S., Chi, K., et al.[2018]

A new transition program called 'Transition with a heart' has been developed for adolescents with congenital heart disease, focusing on promoting autonomy, disease knowledge, and continuity of care as they move to adult healthcare.

This program includes essential components like individualized care plans, adolescent-centered communication, and a transition coordinator, aiming to ensure that young patients are well-prepared to manage their health as they grow into adulthood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a transition program for adolescents with congenital heart disease. de Hosson, M., De Backer, J., De Wolf, D., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a provisional model to improve transitional care for female adolescents with a rare genital malformation as an example for orphan diseases. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

"I can't pose a whole heap of questions that I know I don't have time to follow up"-Exploring perceptions of an adolescent transition program. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of Interventions Aimed at Facilitating Successful Transition Planning and Transfer to Adult Care Among Youth with Chronic Illness. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Transition-oriented patient education program for adolescents and young adults with ADHD]. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Young people with chronic illness: the approach to transition. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Connecting with Families through Virtual Perinatal Education during the COVID-19 Pandemic. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Virtual Skills Training Format for Teaching Intrauterine Contraception Insertion During Coronavirus Disease 2019. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Homeschooling Surgery Students: Washington State University's Longitudinal Integrated Clerkship Transitioned to a Hybrid-Virtual Platform Triggered by the COVID-19 Pandemic. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Utilization of virtual learning environments in the allied health professions. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Improving the efficiency of virtual insulin teaching for patients admitted to hospital through the COVID-19 pandemic: a quality improvement initiative. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Provision of Transition Education and Referral Patterns from Pediatric Cardiology to Adult Cardiac Care. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Development of a transition program for adolescents with congenital heart disease. [2021]