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A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia

Primary Purpose

Congenital Adrenal Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual educational based transition intervention self-paced
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Adrenal Hyperplasia focused on measuring Self-Paced, Interactive, Adrenal Biomarkers, Trxansition Index Score, Health Care Transition

Eligibility Criteria

16 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed assent or consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Patients between ages 16-22 Diagnosed with CAH and enrolled in the Natural History Study Protocol 06-CH-0011. 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. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Patients with significant medical or cognitive impairment(s) that may interfere with participating in trial. Participants unable to participate in all aspects of this clinical trial.

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

UNC Trxansition Index measure
The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.

Secondary Outcome Measures

Disease-specific knowledge
Disease-specific knowledge
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Degree of disease control based on two commonly used adrenal biomarkers
Degree of disease control based on two commonly used adrenal biomarkers
HRQoL based on Short Form Health Survey (SF-36).
HRQoL based on Short Form Health Survey (SF-36).
Number of hospitalizations per year related to CAH
Number of hospitalizations per year related to CAH
Number of school/work absences per year related to CAH
Number of school/work absences per year related to CAH

Full Information

First Posted
December 22, 2022
Last Updated
October 5, 2023
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT05663320
Brief Title
A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia
Official Title
A Feasibility Pilot Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 3, 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Children with congenital adrenal hyperplasia (CAH) can survive well into adulthood with proper treatment. But the change from pediatric to adult care can be challenging. Many people with CAH need extra support as they learn to take control of their own health care needs. Researchers have studied how people respond to different types of patient education. Now researchers want to find out if virtual education, via computer, is a good way to teach people how to manage CAH as they become adults. Objective: To test a virtual method of delivering patient education to adolescents and young adults with CAH. Eligibility: Adolescents and young adults aged 16 to 22 years who have CAH. They must already be enrolled in Natural History Study Protocol 06-CH-0011. Design: Participants may take part in the study remotely; they may also come to the clinic. They will have 3 visits in 1 year. Participants will complete questionnaires. Topics will include what they know about CAH; whether they remember to take their medications on their own; and whether they schedule their own appointments. They will be asked about their quality of life. They will be asked about their physical and emotional health. All participants will be taught how to care for themselves. The participants will be divided into 2 groups. Some will watch an 11-minute video on CAH that focuses on their goals as they become adults. The others will receive standard education. After 6 months, participants will receive CAH education again. After 12 months, participants will repeat the questionnaires from their first visit.
Detailed Description
Study Description: Health Care Transition (HCT) is defined as planned movement of chronically ill youth and young adults from a child to an adult model of care. HCT initiatives aim to facilitate the transition process and reduce commonly observed complications associated with poor transition such as decreased health literacy, poor treatment adherence, discontinuity of care and poor medical outcomes. The NIH Clinical Center is a unique environment where children with rare diseases such as Congenital Adrenal Hyperplasia (CAH) are often followed longitudinally into adulthood. Rare diseases are understudied and few studies have investigated effective ways of delivering HCT focused education to improve transition readiness. This is a pilot, randomized controlled trial that will assess the feasibility and preliminary efficacy of a virtual education-based transition intervention to improve transition readiness in adolescents and young adults with CAH. We hypothesize that the virtual education-based transition intervention will be feasible and participants in the intervention arm, will have better transition readiness score, disease outcomes and quality of life as compared to participants who received usual care. Objectives: Primary objective: To assess the feasibility of a virtual education based transition intervention in adolescents and young adults with CAH. Secondary Objective: To assess preliminary effectiveness of a virtual education-based transition intervention on measures of transition readiness. Endpoints: Primary Endpoint: a) study participant compliance rate of >= 67% with virtual education-based transition intervention, and b) feasibility of collecting all study questionnaires from >=75% of participants at all time periods. Secondary Endpoint: The change in baseline to 12 months in the University of North Carolina (UNC) Trxansition Index score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia
Keywords
Self-Paced, Interactive, Adrenal Biomarkers, Trxansition Index Score, Health Care Transition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
virtual educational based transition intervention self-paced
Intervention Description
study intervention is a standardized, virtual educational video on CAH that will be delivered self-paced
Primary Outcome Measure Information:
Title
UNC Trxansition Index measure
Description
The UNC Trxansition Index is a validated, provider-administered transition readiness questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Disease-specific knowledge
Description
Disease-specific knowledge
Time Frame
12 months
Title
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Description
Self-Management and Transition to Adulthood with Rx (STARx) questionnaire
Time Frame
12 months
Title
Degree of disease control based on two commonly used adrenal biomarkers
Description
Degree of disease control based on two commonly used adrenal biomarkers
Time Frame
12 months
Title
HRQoL based on Short Form Health Survey (SF-36).
Description
HRQoL based on Short Form Health Survey (SF-36).
Time Frame
12 months
Title
Number of hospitalizations per year related to CAH
Description
Number of hospitalizations per year related to CAH
Time Frame
12 months
Title
Number of school/work absences per year related to CAH
Description
Number of school/work absences per year related to CAH
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed assent or consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Patients between ages 16-22 Diagnosed with CAH and enrolled in the Natural History Study Protocol 06-CH-0011. 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. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Patients with significant medical or cognitive impairment(s) that may interfere with participating in trial. Participants unable to participate in all aspects of this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth W Parker, C.R.N.P.
Phone
(301) 496-8533
Email
ruth.parker@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth W Parker, C.R.N.P.
Organizational Affiliation
National Institutes of Health Clinical Center (CC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY dial 711
Email
ccopr@nih.gov

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000411-CC.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia

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