iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis

Study Overview
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Brief Summary
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This study will look at the use and impact of smartphone application (app) for adolescents with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project will include three studies. First, the investigators conducted usability sessions with adolescents with JIA to refine the app so that it is usable, acceptable and understandable. The aim of this study is to look at (a) how regularly the iCanCope with Pain app is used and (b) any effect the app has on young people's health. This study will compare two groups of young people: one that is using the new app, and one that receives usual medical care.

Official Title
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iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Behavioral: iCanCope app
* Behavioral: iCanCope attention control app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Aged 12-18 years Diagnosed with JIA (36) as per their rheumatologist Able to speak and read English Have self-reported average arthritis-related pain in the past week of >3 on 10cm visual analogue scale (VAS) Willing to complete online study outcome measures Exclusion Criteria: Moderate to severe cognitive impairments as per their healthcare provider Major co-morbid psychiatric [conversion disorder, depression, anxiety disorder] illnesses that may impact their ability to understand and use the iCanCope with Pain intervention as per their rheumatologist Received more than 4 CBT sessions for pain management in the past 6 months, as per their healthcare provider and self-report Patients from the department of haematology/oncology

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCanCope app<br>iCanCope app | Behavioral: iCanCope app<br>* In addition to standard medical care, adolescents in the experimental group will receive access to the iCanCope smartphone app for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component.<br>|
| Active Comparator: Attention control app<br>Control group: iCanCope attention control app | Behavioral: iCanCope attention control app<br>* The control group is designed to control for the potential effects on outcomes of time, attention, and smartphone use during the intervention. In addition to standard medical care, adolescents in the attention control group will receive access to the iCanCope control app, with limited functionality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant accrual rate | Centrally tracked by the clinical research project coordinator | 8 weeks | 
| Number of issues or difficulties in implementing the intervention | The intervention fidelity log will track any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. | 8 weeks | 
| Acceptability of intervention | Participants in the intervention arm will complete the Acceptability e-scale (AES) post-intervention. In addition, a subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore acceptability of the intervention. | 8 weeks | 
| Frequency of login per user | Measured through the iCanCope server. | 8 weeks | 
| Adherence | Adherence will be determined using Google Analytics. | 8 weeks | 
| Adverse Events | Adverse events will be tracked using an adverse event form | 8 weeks | 
| Participant dropout rate | Centrally tracked by clinical research project coordinator | 8 weeks | 
| Satisfaction of intervention | A subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore satisfaction of the intervention. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be 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. This online measure takes 3 - 5 minutes to complete, and has evidence of test-retest reliability, construct validity, and responsiveness. | 8 weeks | 
| Pain-Related Activity Limitations | Pain-related activity limitations will be measured using the Child Activity Limitations Interview (CALI-21). This is a well-validated 21-item self-report scale divided into (i) active (e.g., gym, sports) and (ii) routine (e.g., schoolwork, reading) activity subscales. | 8 weeks | 
| Pain coping | Pain coping will be measured using the Pain Coping Questionnaire which is an internationally used measure of pain coping strategies in pediatric populations. Respondents indicate on a 5-point scale how often they use a given type of coping strategy from among 8 different categories. Three higher order factor-derived subscale scores will be used for analyses, including approach coping (e.g., problem-solving), problem-focused avoidance coping (e.g., cognitive distraction), and emotion-focused avoidance coping (e.g., catastrophizing). The measure is considered to meet psychometric criteria for a well-established coping measure and is responsive to pain coping interventions. | 8 weeks | 
| Health-Related Quality of Life (HRQoL) | HRQoL will be measured using the PedsQL 3.0 Arthritis Module, which measures the potential impact on quality of life of having arthritis in childhood. The scale has 22 items and evaluates the severity of perceived problems with disease symptoms, daily activity limitations, treatments, worry/anxiety, and communication. | 8 weeks | 
| Health care utilization form | This will be used to measure direct health care costs and patient/family out of pocket costs related to arthritis care | 8 weeks | 
| Health Utility Index | Used to calculate quality adjusted life years (QALYs) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Self-management, Pain