Growing up With the Young Endocrine Support System (YESS!) (YESS)

September 6, 2023 updated by: dr. Laura C. G. de Graaff-Herder

Growing up With the Young Endocrine Support System (YESS!): Innovative E-technology to Improve Transition From Paediatric to Adult Care

Transition from paediatric to adult endocrinology is a challenge for adolescents, families and doctors. Up to 25% of young adults with chronic endocrine disorders are lost to follow-up ('drop-out') once the young adult moves out of paediatric care. Non-attendance and sub-optimal medical self-management can lead to serious and expensive medical complications. In a pilot study, adolescents suggested the use of e-technology to become more involved in the transition process. The investigators have designed and developed the YESS! game, a tool to help improve medical self-management in adolescents with chronic endocrine disorders. The hypothesis is that adolescents playing the YESS! game will show a larger increase in self-management score during the first year of transition and will have a lower drop-out rate at the adult endocrine outpatient clinic (OPC), compared to adolescents who do not play the game.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Transition from paediatric to adult endocrinology is a challenge for adolescents, families and doctors. Up to 25% of young adults with chronic endocrine disorders are lost to follow-up ('drop-out') once the young adult moves out of paediatric care. Non-attendance and sub-optimal medical self-management can lead to serious and expensive medical complications. In a pilot study, adolescents suggested the use of e-technology to become more involved in the transition process. The investigators have designed and developed the YESS! game, a tool to help improve medical self-management in adolescents with chronic endocrine disorders. The hypothesis is that adolescents playing the YESS! game will show a larger increase in self-management score during the first year of transition and will have a lower drop-out rate at the adult endocrine outpatient clinic (OPC), compared to adolescents who do not play the game.

Objective: 1.To improve medical self-management. 2.To prevent drop-out from the adult outpatient clinic. Study design: multicentre randomized controlled trial Study population: 160 transition patients from 15 to 20 years old from the participating countries Spain, The United Kingdom, Belgium and the Netherlands. Patients are diagnosed with a chronic endocrine disorder. Intervention: The study consists of 4 study arms: receiving the YESS! game and toolkit (group YT), receiving the control game and toolkit (group GT), receiving the toolkit only (group T) and receiving regular transition care (group O). Every group will receive regular transition care. The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management. Main study parameters: Primary outcome: the Self-management and Transition to Adulthood with Rx (=treatment) (STARx) questionnaire score 12 months after inclusion in group YT compared to group O. Secondary outcome: the STARx questionnaire score 6 months after inclusion in group YT compared to the other study groups, the STARx questionnaire score 12 months after inclusion in group YT compared to group GT and T and the drop-out rate to the adult outpatient clinic in the first year after the last visit to the paediatric endocrinologist (i.e. one year after the moment of transfer) in group YT compared to groups GT, T and O.

Nature and extent of the burden and risks associated with participation: The participants are not exposed to any risks. The YESS! and the control game are safe apps played on a mobile phone or tablet. The burden consists of filling out the STARx questionnaires and playing the YESS! or control game. The questionnaires will be filled out online at home at the start of the study and after 6 and 12 months. Every 6 months the subject has an appointment at the outpatient clinic. The participant can play the YESS! game for a maximum of 15 minutes a day to prevent game addiction. The control game could be played for an unlimited amount of time, but will unlikely cause game addiction since the game is not considered challenging and exciting enough.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital
  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Erasmus Medical Center
        • Contact:
        • Sub-Investigator:
          • Sabine E Hannema
  • Spain
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G51 4TF
      • London, United Kingdom, E1 1BB
      • London, United Kingdom, NW1 2PG
        • University College London Hospital (UCL Institute of Child Health)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 15 to 20 years old.
  • Diagnosed with congenital adrenal hyperplasia, hypogonadotropic hypogonadism, Turner syndrome, Klinefelter syndrome, growth hormone deficiency, combined pituitary hormone deficiency, Androgen insensitivity syndrome, thyroid dysgenesis or Addison's disease

Exclusion Criteria:

  • Lack of a mobile phone or tablet.
  • Intellectual disability or language barrier leading to inability to use the YESS! game or the control game.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group YT
Group receives YESS! game and transition-toolkit
Device: YESS! game

The YESS! game is a real-life game for smartphone or tablet in which the player has to solve a mystery. The adolescent plays an active role in the course of the story. This results in an interactive experience. During the game, the adolescent is challenged with regard to self-management and responsible behaviour in general life, with parallels to medical selfmanagement and responsible behaviour.

The adolescent has to decide at several different moments whether to take action or not, whether to accept help or not and whether to share (fictive) confidential information or not. Other aspects that are covered are 'taking responsibility' and 'being on time'. The choices the adolescent makes throughout the game are registered in a coded manner, for later analysis. The game is available in Dutch, English and Spanish.

Other: Transition-toolkit
The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
Experimental: Group GT
Group receives control game and transition-toolkit
Other: Transition-toolkit
The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
Device: Snake '97
Snake '97 is a game for smartphone or tablet which is free and can be downloaded in the App Store. The game is a remake of the original snake on the mobile phone in 1997 in which the player moves the snake around and makes the snake 'consume food' (little dots) which causes the snake to grow longer. The goal is to make the snake as large as possible. The game has 12 difficulty levels.
Other Names:
  • control game
Experimental: Group T
Group receives transition-toolkit
Other: Transition-toolkit
The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
No Intervention: Group O
Group receives usual transition care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical self-management group YT compared to group O @12months
Time Frame: 12 months
The difference in Self-management and Transition to Adulthood with Rx (treatment) (STARx) questionnaire score from baseline after 12 months in participants receiving the YESS! game and toolkit (group YT) compared to participants receiving regular care (group O).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical self-management group YT compared to group GT and -T @12months
Time Frame: 12 months

The difference in Self-management and Transition to Adulthood with Rx (treatment) (STARx) questionnaire score from baseline after 12 months in participants receiving the YESS! game and toolkit (group YT) compared to participants receiving the control game and toolkit (group GT) and participants receiving the toolkit only (group T).

Transition to Adulthood with Rx (treatment) (STARx) questionnaire score in group YT compared to group GT and group T after 12 months.
12 months
Medical self-management in group YT compared to group GT, -T and -O @6months
Time Frame: 6 months
The difference in Self-management and Transition to Adulthood with Rx (treatment) (STARx) questionnaire score from baseline after 6 months in participants receiving the YESS! game and toolkit (group YT) compared to participants receiving the control game and toolkit (group GT), participants receiving the toolkit only (group T) and participants receiving regular care (group O).
6 months
Drop-out rate adult outpatient clinic
Time Frame: 12 months
The difference in the drop-out rate to the outpatient clinic in group YT compared to group GT, group T and group O during the first year after the last visit to the paediatric endocrinologist (i.e. one year after the moment of transfer, t=24 m).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

dr. Laura C. G. de Graaff-Herder

Investigators

  • Principal Investigator: Laura CG de Graaff, MD PhD, Erasmus Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL.69953.078.19
  • NL8097 (Other Identifier: Netherlands Trial Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD has not been finalized yet. The investigators intent to share the full anonymized dataset, study protocol and statistical analysis plan upon request after publication of the results. Informed consent forms will not be shared."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Adrenal Hyperplasia

Clinical Trials on YESS! game

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe