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

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ClinicalTrials.gov Identifier: NCT04252001
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Laura C. G. de Graaff-Herder, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Congenital Adrenal Hyperplasia Hypogonadotropic Hypogonadism Growth Hormone Deficiency Combined Pituitary Hormone Deficiency Turner Syndrome Klinefelter Syndrome Addison's Disease Androgen Insensitivity Syndrome Thyroid Dysgenesis Device: YESS! game Device: Snake '97 Other: Transition-toolkit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Growing up With the Young Endocrine Support System (YESS!): Innovative E-technology to Improve Transition From Paediatric to Adult Care
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023


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
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 Name: control game

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

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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).

  3. 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).



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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252001


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Netherlands
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Contact: Laura CG de Graaff, MD, PhD    +31618843010    l.degraaff@erasmusmc.nl   
Sub-Investigator: Sabine E Hannema         
Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Contact: Jesús Argente       jesus.argente@fundacionendo.org   
United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Royal Hospital for Children
Glasgow, United Kingdom, G51 4TF
Contact: Mohammed G Shaikh       guftar.shaikh@nhs.net   
The Royal London Hospital (Barts Health NHS Trust)
London, United Kingdom, E1 1BB
Contact: Ruben Willemsen       ruben.willemsen@nhs.net   
University College London Hospital (UCL Institute of Child Health)
London, United Kingdom, NW1 2PG
Contact: Gary E Butler       gary.butler@ucl.ac.uk   
Sponsors and Collaborators
dr. Laura C. G. de Graaff-Herder
Investigators
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Principal Investigator: Laura CG de Graaff, MD PhD Erasmus Medical Centre
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Responsible Party: dr. Laura C. G. de Graaff-Herder, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04252001    
Other Study ID Numbers: NL.69953.078.19
NL8097 ( Other Identifier: Netherlands Trial Register )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. Laura C. G. de Graaff-Herder, Erasmus Medical Center:
Serious game
Endocrinology
Transition
Additional relevant MeSH terms:
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Turner Syndrome
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Klinefelter Syndrome
Androgen-Insensitivity Syndrome
Thyroid Dysgenesis
Hypogonadism
Addison Disease
Syndrome
Hyperplasia
Endocrine System Diseases
Disease
Pathologic Processes
Gonadal Disorders
Gonadal Dysgenesis
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases