Development of Healthcare Transition for Patients With Congenital Adrenal Hyperplasia

NCT07611786 | Not Yet Recruiting

• 2 other identifiers: 300016530Neurocrine Biosciences
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to implement and evaluate the feasibility and acceptability of a structured healthcare transition program for adolescents and young adults with congenital adrenal hyperplasia (CAH). The study will also examine preliminary effects of the program on transition readiness, disease-specific self-management knowledge, emergency preparedness, continuity of endocrine care, and health-related quality of life as participants transition from pediatric to adult healthcare services.

Conditions

Congenital Adrenal Hyperplasia

Keywords

congenital adrenal hyperplasia; healthcare transition

Outcome Measures

Primary Outcomes (3)

• assessment of CAH knowledge

  Brief survey of CAH knowledge with Congenital adrenal hyperplasia knowledge questionnaire looking at the treatment of the condition and the mechanism of congenital adrenal hyperplasia. Minimum score 0; Maximum score 44; with 0 indicating lack of knowledge of CAH

  at baseline, 6 months, and 12 month after initiation of healthcare transition readiness

• Self-Management and Transition to Adulthood with Rx (Self-Management and Transition to Adulthood with Rx-parent) questionnaire regarding transtion readiness

  This questionnaire assesses patient's readiness for movement to adult healthcare. minimum score of 0, maximum score of 90. 0 indicating patient is not ready for movement to the adult healthcare system.

  at baseline, 6 months and after 12 month visit

• Change in quality of life for patients with CAH

  assessment of CAH quality of life with questionnaire (CAHQL). Scale from 0-100 with increasing scale indicating a higher quality of life.

  at baseline, and 6 and 12 month follow-up

Secondary Outcomes (4)

• number of participants that receive the emergency preparedness checklist

  baseline, 6 months, and 12 months after initiation of transition protocol

• number of visits a participant requires for acute care

  baseline, 6 months and 12 months after initiation of healthcare transition protocol

• Assess satisfaction and experience survey

  after completion of 12 month visit of health care transition protocol

• themes regarding CAH healthcare transition

  up to 24 months

Study Arms (3)

adolescent and young adult with congenital adrenal hyperplasia

Other: exposure to healthcare transition protocol

guardian/caregiver of adolescent/young adult with congenital adrenal hyperplasia

Other: exposure to healthcare transition protocol

clinical provider of patients with congenital adrenal hyperplasia

Other: exposure to healthcare transition protocol

Interventions

exposure to healthcare transition protocol OTHER

CAH-T Curriculum Visits CAH-T Visit 1 (V1) CAH-T Visit 1 will occur approximately 3 months after enrollment and will include: * Review of CAH disease management * Stress dosing education * Emergency hydrocortisone instruction * Medical alert education * Teach-back demonstration of emergency injection technique * Discussion of adherence, mental health, fertility/sexual health, bone health, and cardiometabolic health * Introduction to healthcare transition concepts * Development of individualized transition goals For participants aged ≥18 years: * Identification of adult endocrinology provider * Development of transfer plan * Medical summary review/update Relevant educational materials are included in attachments. CAH-T Visit 2 (V2) CAH-T Visit 2 will occur approximately 6 months after enrollment and will include: * Reinforcement of CAH self-management concepts * Review of emergency preparedness * Review of transfer readiness * Finalization of transfer planning

adolescent and young adult with congenital adrenal hyperplasia; clinical provider of patients with congenital adrenal hyperplasia; guardian/caregiver of adolescent/young adult with congenital adrenal hyperplasia

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This population will be recruited from our pediatric endocrinology clinic as available.

You may qualify if:

• YA Participants
• Diagnosis of congenital adrenal hyperplasia (any subtype or severity)
• Age ≥16 years
• Active follow-up within the pediatric endocrinology clinic
• English-speaking
• Cognitively able to complete questionnaires with or without assistance
• Anticipated ability to participate in CAH-T visits during the study period Caregiver Participants
• Parent, guardian, or primary support person of an enrolled AYA participant Provider Participants
• Pediatric endocrinologists, nurse practitioners, or transition-related clinical staff involved in CAH care for at least 6 months

You may not qualify if:

• Significant cognitive impairment precluding participation
• Inability to complete study procedures
• Inability to provide informed consent/assent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Neurocrine Biosciences: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Christy Foster, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Foster, MD

CONTACT

205-638-9107; cafoster@uabmc.edu

Leslie Pitts, PHD

CONTACT

lesliepitts@uab.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: primary investigator

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 28, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)