Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents
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|ClinicalTrials.gov Identifier: NCT02610166|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Behavioral: Game Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Access to the game.
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.
Active Comparator: Usual Care
Other: Usual Care
Children in usual care group receive standard medical care.
- 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).
- Pain [ Time Frame: 8 weeks ]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.
- Pain-related Activity Limitations [ Time Frame: 8 weeks ]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.
- Health-related Quality of Life [ Time Frame: 8 weeks ]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.
- Self Efficacy [ Time Frame: 8 weeks ]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.
- JIA-specific Disease Knowledge [ Time Frame: 8 weeks ]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.
- Adherence [ Time Frame: 8 weeks ]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.
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): NCT02610166
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada|
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada|
|London, Ontario, Canada|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Montreal Children's Hospital|
|Montreal, Quebec, Canada|