Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610166
• Other study ID #: 1000048447
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

1. Age = 8 and = 11 years of age

2. Diagnosed with JIA (minimum 3 months) using International League of Associations for Rheumatology classification criteria96

3. Active disease

4. Child and primary parent/caregiver are able to speak and read English or French

5. Participants are willing and able to complete online measures

Exclusion Criteria:

1. Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)

2. 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).

3. Children currently participating in other Cognitive Behavioural Therapy (CBT) interventions

4. Usability testing participants

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Behavioral:
• 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.

Other:
• Usual Care
Children in usual care group receive standard medical care.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (13)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Alberta Children's Hospital, Children's Hospital of Eastern Ontario, Children's Hospital of Western Ontario, IWK Health Centre, McGill University, Memorial University of Newfoundland, Montreal Children's Hospital of the MUHC, Provincial Health Services Authority, St. Justine's Hospital, University of Florida, University of Kansas Medical Center, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Accrual	This will be centrally tracked by the clinical research project coordinator (CRPC).	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Engagement with Intervention	Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).	8 weeks
Primary	Dropout Rates	This will be centrally tracked by the clinical research project coordinator (CRPC).	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks