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

NCT04252001 | Not Yet Recruiting

• 2 other identifiers: NL.69953.078.19NL8097
• Study Type: interventional
• Target: 160
• Locations: 4 countries
• Sites: 7

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.

Conditions

Congenital Adrenal Hyperplasia; Hypogonadotropic Hypogonadism; Growth Hormone Deficiency; Combined Pituitary Hormone Deficiency; Turner Syndrome; Klinefelter Syndrome; Addison's Disease; Androgen Insensitivity Syndrome; Thyroid Dysgenesis

Keywords

Serious game; Endocrinology; Transition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Medical self-management group YT compared to group GT and -T @12months

  12 months

• Medical self-management in group YT compared to group GT, -T and -O @6months

  6 months

• Drop-out rate adult outpatient clinic

  12 months

Study Arms (4)

Group YT

EXPERIMENTAL

Group receives YESS! game and transition-toolkit

Device: YESS! game; Other: Transition-toolkit

Group GT

EXPERIMENTAL

Group receives control game and transition-toolkit

Device: Snake '97; Other: Transition-toolkit

Group T

EXPERIMENTAL

Group receives transition-toolkit

Other: Transition-toolkit

Group O

NO INTERVENTION

Group receives usual transition care

Interventions

YESS! game DEVICE

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.

Group YT

Snake '97 DEVICE

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.

Also known as: control game

Group GT

Transition-toolkit OTHER

The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.

Group GT; Group T; Group YT

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• dr. Laura C. G. de Graaff-Herder: lead

Study Sites (7)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Royal Hospital for Children

Glasgow, G51 4TF, United Kingdom

Location

The Royal London Hospital (Barts Health NHS Trust)

London, E1 1BB, United Kingdom

Location

University College London Hospital (UCL Institute of Child Health)

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital; Hypogonadism; Dwarfism, Pituitary; Combined Pituitary Hormone Deficiency; Turner Syndrome; Klinefelter Syndrome; Addison Disease; Androgen-Insensitivity Syndrome; Thyroid Dysgenesis

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gonadal Dysgenesis; Sex Chromosome Disorders of Sex Development; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Sex Chromosome Disorders; Chromosome Disorders; Adrenal Insufficiency; Autoimmune Diseases; Immune System Diseases; Disorder of Sex Development, 46,XY; Genetic Diseases, X-Linked; Thyroid Diseases

Study Officials

• Laura CG de Graaff, MD PhD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 5, 2020
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); ES (1); GB (4); NL (1)