Congenital Adrenal HyperplasiaYESSNCT04252001
Growing up With the Young Endocrine Support System (YESS!)
A study testing YESS! game, Snake '97 and Transition-toolkit in people with Congenital Adrenal Hyperplasia and Hypogonadotropic Hypogonadism, run by dr. Laura C. G. de Graaff-Herder at 7 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia, Hypogonadotropic Hypogonadism, Growth Hormone Deficiency
- What is being tested?
- YESS! game, Snake '97 and Transition-toolkit
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Lack of a mobile phone or tablet.
- Intellectual disability or language barrier leading to inability to use the YESS! game or the control game.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United Kingdom4 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Royal Hospital for Children
Glasgow, G51 4TF
Mohammed G Shaikh, guftar.shaikh@nhs.net
The Royal London Hospital (Barts Health NHS Trust)
London, E1 1BB
Ruben Willemsen, ruben.willemsen@nhs.net
University College London Hospital (UCL Institute of Child Health)
London, NW1 2PG
Gary E Butler, gary.butler@ucl.ac.uk
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Laura CG de Graaff, MD, PhD, +31618843010, l.degraaff@erasmusmc.nl
Sabine E Hannema
Spain1 site
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
Jesús Argente, jesus.argente@fundacionendo.org
About this study
Official title: Growing up With the Young Endocrine Support System (YESS!): Innovative E-technology to Improve Transition From Paediatric to Adult Care
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.
Read the 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.
- Conditions
- Congenital Adrenal Hyperplasia, Hypogonadotropic Hypogonadism, Growth Hormone Deficiency, Combined Pituitary Hormone Deficiency, Turner Syndrome, Klinefelter Syndrome
- Being tested
- YESS! game, Snake '97, Transition-toolkit
- Keywords
- Serious game, Endocrinology, Transition
- Medical subject headings
- Adrenal Hyperplasia, Congenital, Hypogonadism, Dwarfism, Pituitary, Combined Pituitary Hormone Deficiency, Turner Syndrome, Klinefelter Syndrome, Addison Disease, Androgen-Insensitivity Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YESS! gameDevice
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 '97Device
Also called control game
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.
Transition-toolkitOther
The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
| Study group | Role | What they receive |
|---|---|---|
| Group YT | Experimental | Group receives YESS! game and transition-toolkit Receives: Device: YESS! game; Other: Transition-toolkit |
| Group GT | Experimental | Group receives control game and transition-toolkit Receives: Device: Snake '97; Other: Transition-toolkit |
| Group T | Experimental | Group receives transition-toolkit Receives: Other: Transition-toolkit |
| Group O | No intervention | Group receives usual transition care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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).
Measured: 6 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. Laura C. G. de Graaff-Herder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Laura C. G. de Graaff-Herder, Erasmus Medical Center
- Investigators
- Laura CG de Graaff, MD PhD, Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252001
- Sponsor's protocol ID
- NL.69953.078.19
- Other IDs
- NL8097
- Acronym
- YESS
- Status last verified
- Sep 2023
- First submitted
- 21 Jan 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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."
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing up With the Young Endocrine Support System (YESS!): Innovative E-technology to Improve Transition From Paediatric to Adult Care
- ClinicalTrials.gov ID
- NCT04252001
- Acronym / sponsor ID
- YESS / NL.69953.078.19
- Conditions
- Congenital Adrenal Hyperplasia, Hypogonadotropic Hypogonadism, Growth Hormone Deficiency, Combined Pituitary Hormone Deficiency, Turner Syndrome, Klinefelter Syndrome
- Keywords
- Serious game, Endocrinology, Transition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- dr. Laura C. G. de Graaff-HerderUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group YT | Experimental | Device: YESS! game, Other: Transition-toolkitGroup receives YESS! game and transition-toolkit |
| Group GT | Experimental | Device: Snake '97, Other: Transition-toolkitGroup receives control game and transition-toolkit |
| Group T | Experimental | Other: Transition-toolkitGroup receives transition-toolkit |
| Group O | No intervention | –Group receives usual transition care |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of a mobile phone or tablet.
- Intellectual disability or language barrier leading to inability to use the YESS! game or the control game.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YESS! gameThe 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. | Device | Group YT |
| Snake '97Also: control gameSnake '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. | Device | Group GT |
| Transition-toolkitThe transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management. | Other | Group GT, Group T, Group YT |
Primary outcome
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura CG de Graaff, MD PhD principal investigator
Erasmus Medical Centre
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YESS! game, Snake '97 and Transition-toolkit in people with Congenital Adrenal Hyperplasia and Hypogonadotropic Hypogonadism, run by dr. Laura C. G. de Graaff-Herder at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Belgium, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical self-management group YT compared to group O @12months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.