Juvenile Idiopathic ArthritisNCT02610166
Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents
A study testing Game in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 7 sites in Canada.
Trial summary
Arthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 7 sitesCanada
- Study dates
- Jan 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 8 and ≤ 11 years of age
- Diagnosed with JIA (minimum 3 months) using International League of Associations for Rheumatology classification criteria96
- Active disease
- Child and primary parent/caregiver are able to speak and read English or French
- Participants are willing and able to complete online measures
Who cannot join
- Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- Major co-morbid illnesses (e.g., medical [inflammatory bowel disease, cancer, diabetes] or psychiatric [depression, anxiety]) which may impact their ability to understand and use the game or complete outcome assessments (as determined by their rheumatologist).
- Children currently participating in other Cognitive Behavioural Therapy (CBT) interventions
- Usability testing participants
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
IWK Health Centre
Halifax, Nova Scotia
Children's Hospital
London, Ontario
CHU Sainte-Justine
Montreal, Quebec
Montreal Children's Hospital
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
About this study
Official title: Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents
Arthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. It is important to create programs that teach children and families how to cope with and manage arthritis. This study will develop and test an online game that helps children learn how to better manage their arthritis. The goal of these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if children who play the game feel less pain, have fewer limitations, and a better quality of life compared to children who do not play the game.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Game, Usual Care
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GameBehavioural
In addition to standard medical care, children in the experimental group will receive the Match-3 game. The game will be designed for short individual gameplay sessions (as little as a few seconds), once to three times a day, over the course of 8 weeks, involving no more than 15 minutes per day in anticipated screen time. There is no way to "lose" the game. Through a structured series of daily interactions, the player will learn strategies and develop decision-making abilities that will assist with management of their own JIA. The Match 3 concept (similar to the game, Bejeweled) will require the player to successfully match the treatment strategy to the JIA symptom.
Usual CareOther
Children in usual care group receive standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Game | Experimental | Access to the game. Receives: Behavioral: Game |
| Usual Care | Active comparator | Control group. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Accrual
This will be centrally tracked by the clinical research project coordinator (CRPC).
Measured: 8 weeks
Intervention Fidelity
Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. For example, issues from a technical standpoint (for example, game not downloading properly, participant requiring assistance using the technology) or logistics standpoint.
Measured: 8 weeks
Acceptability and Satisfaction with Intervention
Immediately post-trial children and parents in the intervention group will rate their acceptability of and satisfaction with the game and 10-15 English and 10-15 French children and one of their parents will take part in a brief qualitative interview.
Measured: 8 weeks
Engagement with Intervention
Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).
Measured: 8 weeks
Dropout Rates
This will be centrally tracked by the clinical research project coordinator (CRPC).
Measured: 8 weeks
Secondary outcomes (6)
Pain
Measured using the Standardized Universal Pain Evaluations for Rheumatology providers for children and youth (SUPERKIDZ). It consists of 4 domains: pain intensity and location (5 items), fatigue (1 item), pain interference/evaluative dimension (10 items), and affective/emotional dimension (4 items) for children ≥ 8 years (and parent proxy report for children 4-8 years). This measure takes 3 - 5 minutes to complete.
Measured: 8 weeks
Pain-related Activity Limitations
Measured using the Child Activity Limitations Interview (CALI-21). This is a 21-item self-report scale divided into (i) active (e.g. gym, sports) and (ii) routine (e.g., schoolwork, reading) activity subscales.
Measured: 8 weeks
Health-related Quality of Life
Measured using the Arthritis Pediatric Quality of Life Inventory (PedsQL). The PedsQL Arthritis Module is a 22-item self-report scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Measured: 8 weeks
Self Efficacy
Measured using the Children's Arthritis Self-Efficacy Scale (CASE). The CASE is a disease specific 11-item self-report measure that is divided into three sub-scales: activity, symptom, and emotion. A 5-point Likert scale is used to rate responses to each item with 1 = "not at all sure" to 5 = "very sure" based on how confident the child is that they can manage disease effects.
Measured: 8 weeks
JIA-specific Disease Knowledge
Measured using the 24-item Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS). MEPS is made up of 4 sub scales (medical issues, exercise, pain, and social support). Items are rated on a 10-cm VAS with higher scores indicating greater disease knowledge.
Measured: 8 weeks
Adherence
Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ) that assesses adherence to prescribed medications, exercises, and wearing of splints over the past 3 months. The CARQ was developed specifically for children with JIA and consists of three sections: (1) responsibility for treatment, (2) child's ability to adhere to the three types of treatment, and (3) perceptions about helpfulness of therapies. Items in the last two sections are rated on 11-point numeric pain rating scale with higher scores indicating better adherence and perceived helpfulness of therapies.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Alberta Children's Hospital, Montreal Children's Hospital of the MUHC, IWK Health Centre, Children's Hospital of Eastern Ontario, St. Justine's Hospital, University of Toronto, McGill University, University of Florida, Children's Hospital of Western Ontario, University of Kansas Medical Center, Memorial University of Newfoundland
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610166
- Sponsor's protocol ID
- 1000048447
- Status last verified
- Jun 2019
- First submitted
- 17 Nov 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents
- ClinicalTrials.gov ID
- NCT02610166
- Acronym / sponsor ID
- 1000048447
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Alberta Children's Hospital, Montreal Children's Hospital of the MUHC, IWK Health Centre, Children's Hospital of Eastern Ontario, St. Justine's Hospital, University of Toronto, McGill University, University of Florida, Children's Hospital of Western Ontario, University of Kansas Medical Center, Memorial University of Newfoundland
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Arthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. It is important to create programs that teach children and families how to cope with and manage arthritis. This study will develop and test an online game that helps children learn how to better manage their arthritis. The goal of these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if children who play the game feel less pain, have fewer limitations, and a better quality of life compared to children who do not play the game.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game | Experimental | Behavioral: GameAccess to the game. |
| Usual Care | Active comparator | Other: Usual CareControl group. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥ 8 and ≤ 11 years of age
- Diagnosed with JIA (minimum 3 months) using International League of Associations for Rheumatology classification criteria96
- Active disease
- Child and primary parent/caregiver are able to speak and read English or French
- Participants are willing and able to complete online measures
Key exclusion criteria (4 listed)
- Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- Major co-morbid illnesses (e.g., medical [inflammatory bowel disease, cancer, diabetes] or psychiatric [depression, anxiety]) which may impact their ability to understand and use the game or complete outcome assessments (as determined by their rheumatologist).
- Children currently participating in other Cognitive Behavioural Therapy (CBT) interventions
- Usability testing participants
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 |
|---|---|---|
| GameIn addition to standard medical care, children in the experimental group will receive the Match-3 game. The game will be designed for short individual gameplay sessions (as little as a few seconds), once to three times a day, over the course of 8 weeks, involving no more than 15 minutes per day in anticipated screen time. There is no way to "lose" the game. Through a structured series of daily interactions, the player will learn strategies and develop decision-making abilities that will assist with management of their own JIA. The Match 3 concept (similar to the game, Bejeweled) will require the player to successfully match the treatment strategy to the JIA symptom. | Behavioural | Game |
| Usual CareChildren in usual care group receive standard medical care. | Other | Usual Care |
Primary outcome
Participant Accrual
Time frame: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
Intervention Fidelity
Time frame: 8 weeks
Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. For example, issues from a technical standpoint (for example, game not downloading properly, participant requiring assistance using the technology) or logistics standpoint.
Acceptability and Satisfaction with Intervention
Time frame: 8 weeks
Immediately post-trial children and parents in the intervention group will rate their acceptability of and satisfaction with the game and 10-15 English and 10-15 French children and one of their parents will take part in a brief qualitative interview.
Engagement with Intervention
Time frame: 8 weeks
Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).
Dropout Rates
Time frame: 8 weeks
This will be centrally tracked by the clinical research project coordinator (CRPC).
6 secondary outcomes
Pain
Time frame: 8 weeks
Pain-related Activity Limitations
Time frame: 8 weeks
Health-related Quality of Life
Time frame: 8 weeks
Self Efficacy
Time frame: 8 weeks
JIA-specific Disease Knowledge
Time frame: 8 weeks
Adherence
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 7 sites in Canada.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Accrual (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 18 Jun 2019.