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

Growth Hormone Deficiency Clinical Trial

— YESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04252001
• Other study ID #: NL.69953.078.19
• Secondary ID: NL8097
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Addison Disease
• Addison's Disease
• Adrenal Hyperplasia, Congenital
• Adrenogenital Syndrome
• Androgen Insensitivity Syndrome
• Combined Pituitary Hormone Deficiency
• Congenital Adrenal Hyperplasia
• Endocrine System Diseases
• Growth Hormone Deficiency
• Hyperplasia
• Hypogonadism
• Hypogonadotropic Hypogonadism
• Klinefelter Syndrome
• Syndrome
• Thyroid Dysgenesis
• Turner Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Spain	Hospital Infantil Universitario Niño Jesús	Madrid
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
dr. Laura C. G. de Graaff-Herder

Countries where clinical trial is conducted

Belgium,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical self-management group YT compared to group O @12months	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	Medical self-management group YT compared to group GT and -T @12months	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
Secondary	Medical self-management in group YT compared to group GT, -T and -O @6months	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
Secondary	Drop-out rate adult outpatient clinic	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