Virtual Education Program for Congenital Adrenal Hyperplasia
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
678910How 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.
2451112Eligibility 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.
+3 more
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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
References
Development of a provisional model to improve transitional care for female adolescents with a rare genital malformation as an example for orphan diseases. [2018]Deficits of care exist during the transitional period, when young people with ongoing needs of support to achieve their physical, social, and psychological potential are entering adulthood. This study aims to develop a patient oriented, structured provisional model to improve transitional care for adolescents with Mayer-Rokitansky-Kuester-Hauser-Syndrome as an example for orphan diseases, where problems of access and continuity are even more complex. The study is funded by the German Federal Ministry of Education and Research (BMBF-Funding Code 01GY1125). The target patient group are young females with this disorder, treated at the Centre for Rare Genital Malformations in Women (ZSGF), University Hospital of Tuebingen. The study comprises five phases: an appraisal of literature, assessment of patients (n = 25), parents', partners', and health and social care providers' (n = 24) needs and experienced deficits in care and support in a qualitative approach, construction of a provisional model via scenario technique, followed by communicative validation (including interested public, n = 100), preference finding, and identification of patient-oriented quality aims for follow-up. Quantitative data from questionnaires and chart review (as sociodemographic data, nonresponder analysis, and preference rating) are worked up for descriptive statistics. The results provide a platform for the development of future multidisciplinary transitional intervention programs in orphan diseases.
"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]Adolescent transition programs are patient education programs. They are geared towards enabling adolescents with chronic or long-term illnesses to become active partners in their health care and manage their own health. Although there is agreement about their importance, there is not an agreement on content or how they should be delivered. The study reported here was part of the first steps of an action research project.
A Review of Interventions Aimed at Facilitating Successful Transition Planning and Transfer to Adult Care Among Youth with Chronic Illness. [2017]This article reviews studies that developed interventions aimed at facilitating the transition process and/or the transfer of youth with chronic illness to adult programs during the past decade. Three key intervention approaches have been studied. Data assessing the impact of transition coordinators suggest that the most successful outcomes occur when coordinators meet with patients prior to the transfer of care, support them as they negotiate the adult programs, and facilitate appointment keeping. Data assessing the impact of transition clinics suggest that the key to positive outcomes is helping patients develop a trusting relationship with the adult providers before fully transferring their care to the adult clinic. Similar conclusions can be drawn for transition programs, where it appears that the opportunity to discuss and plan transition with a pediatric provider over time and to meet with both the pediatric and adult providers simultaneously are beneficial for facilitating successful transfer to adult care. Although aspects of these care processes appear promising for improving transition success, this review identifies areas that need further study. We argue that studies are needed that examine individual patient and family-focused interventions as well as looking at other potential interventions in the health care system. [Pediatr Ann. 2017;46(5):e182-e187.].
[Transition-oriented patient education program for adolescents and young adults with ADHD]. [2023]Transition-oriented patient education program for adolescents and young adults with ADHD Abstract. Background: The transition from child- to adult-centered treatment includes numerous challenges in the treatment of chronic disorders. This process can be further complicated by disease-specific characteristics of attention-deficit/hyperactivity disorders (ADHD). This secondary analysis evaluated a transition workshop in individuals with ADHD. Methods: In total, 56 adolescents and young adults with ADHD (age M = 17.3 years, SD = 1.1; 17.9 % female) and their parents were quasi-randomly assigned to a control group (CG, n = 28) or an intervention group (IG, n = 28). The CG received regular medical care, whereas the IG additionally participated in a one-and-a-half-day transition workshop (ModuS-T). Before and 4 weeks after the intervention, transition competence was assessed with the Transition Competence Scale (TKS), patient activation with the Patient Activation Measure 13 for Adolescents (PAM® 13), and satisfaction with care with the Patient Satisfaction Questionnaire (ZUF-8). Results: The IG showed significantly improved transition competence (p ≤ .001) compared to the CG. There was no significant intervention effect in terms of patient activation (p = .194). Overall, the IG was highly satisfied with the workshop. Discussion: To date, transition workshops have been evaluated predominantly in individuals with chronic somatic disorders. This secondary analysis indicates that a generic workshop is also associated with improved transition competence and high satisfaction in individuals with chronic mental disorders. The integration of such approaches into routine care needs to be discussed.
Young people with chronic illness: the approach to transition. [2022]As increasing numbers of young people with chronic illness reach adulthood, their ongoing medical care must evolve to be delivered in an adult rather than paediatric setting, a process known as transition. Towards this goal, increasing numbers of paediatric and adult hospitals are engaging in processes to promote the continuity of care for young people with chronic illness. Increasing evidence shows that adverse health consequences occur when inadequate transition arrangements are in place. This article draws from the experience of a transition programme emanating from the Royal Children's Hospital, Melbourne and describes the preparation that can ensure effective transition of young people with chronic illness to adult institutions. In paediatric settings, this includes opportunities for young people to be seen medically on their own to encourage independence with health-care goals and ensuring that adequate health information is transferred to the adult service. In adult institutions, understanding the concept of adolescent development will encourage young people's engagement with the new health-care providers to improve health outcomes. Joint clinics between paediatric and adult health-care teams can improve the transfer of individual patient knowledge, promote a collaborative approach to patient care, facilitate continuity of care and build confidence from both medical and patient perspectives. Including patients in decision-making processes around transition services will encourage youth-focused service developments that will help achieve optimal outcomes in young people with chronic illness.
Connecting with Families through Virtual Perinatal Education during the COVID-19 Pandemic. [2021]The COVID-19 pandemic has caused many changes in health care. The status quo has been upended. We have been challenged in many ways to maintain our ability to meet the needs of our clients while keeping them safe. The Center for Perinatal Education and Lactation at NYU Langone Hospitals, in one of the initial epicenters of the pandemic in New York City, had to abruptly transition the childbirth education program to a virtual format in March of 2020. The goal for this change was to continue to provide evidence-based support and guidance our to our expectant and new families through this crisis. This report focuses on the process and challenges of transitioning to and implementation of the virtual format in the context of the COVID-19 crisis. We discuss the rapidly evolving programmatic changes to our approach and reflect on the themes and changing landscape of our newly structured model. Questions and answers live discussion webinars "Ask the Educator" on various topics were a valuable tool in connecting with families and allaying anxiety and fear.
Virtual Skills Training Format for Teaching Intrauterine Contraception Insertion During Coronavirus Disease 2019. [2022]The coronavirus disease 2019 pandemic resulted in the curtailment of face-to-face clinical skills training in 2020. To meet Title X workforce needs, the National Clinical Training Center for Family Planning transitioned onsite intrauterine contraception training to a virtual format using online didactic material and livestreamed training and telementoring. Videos demonstrated the placement and removal of intrauterine contraceptives, and all necessary supplies were shipped directly to participants. Attendees reported a high level of skill uptake and impact on their practice. This pilot study suggests that virtual skills training is suitable for providers unable to travel to in-person events.
Homeschooling Surgery Students: Washington State University's Longitudinal Integrated Clerkship Transitioned to a Hybrid-Virtual Platform Triggered by the COVID-19 Pandemic. [2022]When COVID-19 curtailed elective surgeries, our college transitioned to a virtual platform. "Benched" surgeons statewide engaged students online. Third-year students who had completed 2/3 of a longitudinal integrated clerkship (LIC) studied online modules on topics germane to surgery for 1 week. Core entrustable professional activities (EPAs) for entering residency were the backbone of lessons/assignments/assessments. Surgeons coached students around EPAs. Fifty-eight students in consistent small groups, spent 2 hours/day for 4 days with the same pair of surgeon coaches. Off-line, students created a unique hypothetical case/day, practiced and peer-reviewed EPAs. Online, coaches posed scenarios to drill EPAs. Pre/during/post assessments demonstrated progressive proficiency. High level of engagement resulted in 100% attendance and ease of recruitment/retention of faculty. Although variability in students' clinical settings was high, a virtual week had aided in leveling the learning environment. Prior experience with 2/3 of their total surgery exposure in the LIC allowed for a smooth transition to virtual.
Utilization of virtual learning environments in the allied health professions. [2015]Multiple technology based tools have been used to enhance skill development in allied health education, which now includes virtual learning environments. The purpose of this study was to explore whether, and how, this latest instructional technology is being adapted in allied health education. An online survey was circulated to all Association of Schools of Allied Health Professions (ASAHP) member institutions and focused on three broad areas of virtual learning environments: the uses of, the perceived pros and cons of, and the outcomes of utilizing them. Results show 40% (17 of 42) of the respondent use some form of the technology. The use of virtual learning technology in other healthcare professions (e.g., medicine) demonstrates the potential benefits to allied health education.
Improving the efficiency of virtual insulin teaching for patients admitted to hospital through the COVID-19 pandemic: a quality improvement initiative. [2023]Throughout the COVID-19 pandemic, many areas of medicine transitioned to virtual care. For patients with diabetes admitted to hospital, this included diabetes education and insulin teaching. Shifting to a virtual model of insulin teaching created new challenges for inpatient certified diabetes educators (CDE).
Provision of Transition Education and Referral Patterns from Pediatric Cardiology to Adult Cardiac Care. [2018]ACC/AHA guidelines recommend a structured preparation for and transfer to adult-oriented cardiac care for adult survivors of pediatric onset heart disease (POHD). Given this, we sought to describe the transition and transfer practices for a cohort of young adults with POHD and to determine factors associated with successful transfer to adult-oriented cardiac care. We performed a single-center, retrospective chart review on patients ≥18 years of age, with POHD likely to require lifelong cardiac care, who were seen in outpatient pediatric cardiology (PC) between 2008 and 2011. Successful transfer was defined as the subsequent attendance at adult cardiology (AC) within 2 years of PC visit. We identified 118 patients who met study criteria. Mean age 22.4 ± 2.0 years, 59 % male, 64 % white and 40 % Hispanic. Mean transition education topics noted was 3.3 ± 1.8 out of 20 and covered the underlying cardiac disease (89 %), follow-up and current medications (56 %) and exercise limitations (34 %). Recommendations for follow-up were AC (57 %) and PC (33 %). Of those told to transfer to AC, 79 % successfully transferred. Characteristics of successful transfer included: prior cardiac surgery (p = 0.008), cardiac medication use (p = 0.006) and frequency of follow-up ≤1 year (p = 0.037). One-quarter of all subjects did not follow-up within at least 2 years. Despite published guidelines, transition education appears lacking and the approach to transfer to adult cardiac care is not consistent. Given the increased risk of morbidity and mortality in this patient population, standardization of transition education and transfer processes appear warranted.
Development of a transition program for adolescents with congenital heart disease. [2021]Thanks to advances in care, most children with congenital heart disease nowadays survive into adulthood. The majority of patients remain at high risk for future complications. Hence, life-long follow-up is mandatory. Care needs of patients evolve, especially when reaching adulthood. A structured transition period to adult care is advocated. Currently, a fully detailed and structured transition program is not available for patients with congenital heart disease. The aim is to describe the development and design of a multicomponent transition program for adolescents with congenital heart disease, called "Transition with a heart." Transition with a heart was developed based on the Dutch program "On your own feet," starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centered communication, a joined transfer consultation, and an appointed transition coordinator. Adolescents are gradually informed about their condition and potential late consequences in adult life and stimulated to take medical care in their own hands.Conclusion: Transition with a heart is a practical, multicomponent, comprehensive transition program developed to cover the essential aspects of transitional care for adolescents with congenital heart disease (i.e., continuity of care, disease knowledge, and self-management skills). Interventions were selected from the highest sources of scientific evidence currently available.Clinical trial registration: Not applicableWhat is Known:• Transition towards adult life and health care is a complex process, requiring careful patients' guidance. Various task forces have described the need and potential benefits of transition programs in young people with chronic conditions. Details about the practical development and content of such programs in congenital heart disease are, however, currently lacking.What is New:• This method paper presents the development and design of a person-centered multicomponent transition program for adolescents with congenital heart disease comprising interventional components covering the most important aspects of transitional care: promoting autonomy, disease knowledge, and continuity of care.