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

NCT02610166 | Completed

• 1 other identifier: 1000048447
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 7

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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (5)

• Participant Accrual

  This will be centrally tracked by the clinical research project coordinator (CRPC).

  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.

  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.

  8 weeks

• Engagement with Intervention

  Analytics will be used to track patterns of website program usage ("number of interactions" \[clicks\]).

  8 weeks

• Dropout Rates

  This will be centrally tracked by the clinical research project coordinator (CRPC).

  8 weeks

Secondary Outcomes (6)

• Pain

  8 weeks

• Pain-related Activity Limitations

  8 weeks

• Health-related Quality of Life

  8 weeks

• Self Efficacy

  8 weeks

• JIA-specific Disease Knowledge

  8 weeks

Study Arms (2)

Game

EXPERIMENTAL

Access to the game.

Behavioral: Game

Usual Care

ACTIVE COMPARATOR

Control group.

Other: Usual Care

Interventions

Game BEHAVIORAL

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.

Game

Usual Care OTHER

Children in usual care group receive standard medical care.

Usual Care

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Provincial Health Services Authority British Columbia: collaborator
• Alberta Children's Hospital: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• IWK Health Centre: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• St. Justine's Hospital: collaborator
• University of Toronto: collaborator
• McGill University: collaborator
• University of Florida: collaborator
• Children's Hospital of Western Ontario: collaborator
• University of Kansas Medical Center: collaborator
• Memorial University of Newfoundland: collaborator

Study Sites (7)

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Children's Hospital

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist/Clinical Nurse Specialist/NP

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

CA (7)