Growing up With the Young Endocrine Support System (YESS!)
- Conditions
- Growth Hormone DeficiencyAddison's DiseaseCongenital Adrenal HyperplasiaCombined Pituitary Hormone DeficiencyTurner SyndromeKlinefelter SyndromeAndrogen Insensitivity SyndromeThyroid DysgenesisHypogonadotropic Hypogonadism
- Interventions
- Device: YESS! gameDevice: Snake '97Other: Transition-toolkit
- Registration Number
- NCT04252001
- Lead Sponsor
- dr. Laura C. G. de Graaff-Herder
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group YT YESS! game Group receives YESS! game and transition-toolkit Group GT Transition-toolkit Group receives control game and transition-toolkit Group YT Transition-toolkit Group receives YESS! game and transition-toolkit Group GT Snake '97 Group receives control game and transition-toolkit Group T Transition-toolkit Group receives transition-toolkit
- Primary Outcome Measures
Name Time Method Medical self-management group YT compared to group O @12months 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).
- Secondary Outcome Measures
Name Time Method Drop-out rate adult outpatient clinic 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).
Medical self-management group YT compared to group GT and -T @12months 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.Medical self-management in group YT compared to group GT, -T and -O @6months 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).
Trial Locations
- Locations (7)
Ghent University Hospital
🇧🇪Ghent, Belgium
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Spain
Royal Hospital for Children
🇬🇧Glasgow, United Kingdom
The Royal London Hospital (Barts Health NHS Trust)
🇬🇧London, United Kingdom
University College London Hospital (UCL Institute of Child Health)
🇬🇧London, United Kingdom