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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
Sponsor:
Collaborators:
Provincial Health Services Authority
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
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Behavioral: Game Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Game
Access to the game.
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.

Active Comparator: Usual Care
Control group.
Other: Usual Care
Children in usual care group receive standard medical care.




Primary Outcome Measures :
  1. Participant Accrual [ Time Frame: 8 weeks ]
    This will be centrally tracked by the clinical research project coordinator (CRPC).

  2. 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.

  3. 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.

  4. Engagement with Intervention [ Time Frame: 8 weeks ]
    Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).

  5. Dropout Rates [ Time Frame: 8 weeks ]
    This will be centrally tracked by the clinical research project coordinator (CRPC).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Children's Hospital
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Provincial Health Services Authority
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

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Responsible Party: Jennifer Stinson, Clinician Scientist/Clinical Nurse Specialist/NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02610166     History of Changes
Other Study ID Numbers: 1000048447
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases