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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Game
Usual Care
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Children's Hospital
  • IWK Health Centre
  • Children's Hospital
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • CHU Sainte-Justine
  • Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Game

Usual Care

Arm Description

Access to the game.

Control group.

Outcomes

Primary Outcome Measures

Participant Accrual
This will be centrally tracked by the clinical research project coordinator (CRPC).
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.
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.
Engagement with Intervention
Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).
Dropout Rates
This will be centrally tracked by the clinical research project coordinator (CRPC).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 17, 2015
Last Updated
June 17, 2019
Sponsor
The Hospital for Sick Children
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
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1. Study Identification

Unique Protocol Identification Number
NCT02610166
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Game
Arm Type
Experimental
Arm Description
Access to the game.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Control group.
Intervention Type
Behavioral
Intervention Name(s)
Game
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Children in usual care group receive standard medical care.
Primary Outcome Measure Information:
Title
Participant Accrual
Description
This will be centrally tracked by the clinical research project coordinator (CRPC).
Time Frame
8 weeks
Title
Intervention Fidelity
Description
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.
Time Frame
8 weeks
Title
Acceptability and Satisfaction with Intervention
Description
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.
Time Frame
8 weeks
Title
Engagement with Intervention
Description
Analytics will be used to track patterns of website program usage ("number of interactions" [clicks]).
Time Frame
8 weeks
Title
Dropout Rates
Description
This will be centrally tracked by the clinical research project coordinator (CRPC).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
8 weeks
Title
Pain-related Activity Limitations
Description
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.
Time Frame
8 weeks
Title
Health-related Quality of Life
Description
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.
Time Frame
8 weeks
Title
Self Efficacy
Description
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.
Time Frame
8 weeks
Title
JIA-specific Disease Knowledge
Description
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.
Time Frame
8 weeks
Title
Adherence
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Children's Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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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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