Growing up With the Young Endocrine Support System (YESS!)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YESS! game, Snake '97, Transition-toolkit.
- Who it may be relevant to
- Registry conditions: Congenital Adrenal Hyperplasia, Hypogonadotropic Hypogonadism, Growth Hormone Deficiency, Combined Pituitary Hormone Deficiency. Basic parameters: 15 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Growing up With the Young Endocrine Support System (YESS!): Innovative E-technology to Improve Transition From Paediatric to Adult Care
Overview
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.
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.
Interventions
- 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 - 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 Transition-toolkit
The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
Primary outcome measures
- Medical self-management group YT compared to group O @12months [Time frame: 12 months]
Secondary outcome measures (3)
- Medical self-management group YT compared to group GT and -T @12months [Time frame: 12 months]
- Medical self-management in group YT compared to group GT, -T and -O @6months [Time frame: 6 months]
- Drop-out rate adult outpatient clinic [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United Kingdom · 4 centers
- Queen Elizabeth University Hospital — Glasgow
- Royal Hospital for Children — Glasgow
- The Royal London Hospital (Barts Health NHS Trust) — London
- University College London Hospital (UCL Institute of Child Health) — London
Belgium · 1 center
- Ghent University Hospital — Ghent
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Spain · 1 center
- Hospital Infantil Universitario Niño Jesús — Madrid
Identifiers
NCT: NCT04252001 · NL.69953.078.19 · NL8097