Clinical trial NCT02610166: Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents
Official title: Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With Juvenile Idiopathic Arthritis (JIA) and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
name: Alberta Children's Hospital
name: Montreal Children's Hospital of the MUHC
name: IWK Health Centre
name: Children's Hospital of Eastern Ontario
name: St. Justine's Hospital
name: University of Toronto
name: McGill University
name: University of Florida
name: Children's Hospital of Western Ontario
name: University of Kansas Medical Center
name: Memorial University of Newfoundland
First posted: 2015-11-20
Enrollment: 112
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Accrual
timeFrame: 8 weeks
measure: Intervention Fidelity
timeFrame: 8 weeks
measure: Acceptability and Satisfaction with Intervention
timeFrame: 8 weeks
measure: Engagement with Intervention
timeFrame: 8 weeks
measure: Dropout Rates
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain
timeFrame: 8 weeks
measure: Pain-related Activity Limitations
timeFrame: 8 weeks
measure: Health-related Quality of Life
timeFrame: 8 weeks
measure: Self Efficacy
timeFrame: 8 weeks
measure: JIA-specific Disease Knowledge
timeFrame: 8 weeks
measure: Adherence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
References: