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

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Behavioral: iCanCope app; Behavioral: iCanCope attention control app

• Registration Number: NCT02764346
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-06
• Study Start: 2016-07
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Moderate to severe cognitive impairments as per their healthcare provider
2. 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
3. Received more than 4 CBT sessions for pain management in the past 6 months, as per their healthcare provider and self-report
4. Patients from the department of haematology/oncology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCanCope app	iCanCope app	iCanCope app
Attention control app	iCanCope attention control app	Control group: iCanCope attention control app

Primary Outcome Measures

Name	Time	Method
Participant accrual rate	8 weeks	Centrally tracked by the clinical research project coordinator
Number of issues or difficulties in implementing the intervention	8 weeks	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.
Acceptability of intervention	8 weeks	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.
Frequency of login per user	8 weeks	Measured through the iCanCope server.
Adherence	8 weeks	Adherence will be determined using Google Analytics.
Adverse Events	8 weeks	Adverse events will be tracked using an adverse event form
Participant dropout rate	8 weeks	Centrally tracked by clinical research project coordinator
Satisfaction of intervention	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pain	8 weeks	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.
Pain-Related Activity Limitations	8 weeks	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.
Pain coping	8 weeks	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.
Health-Related Quality of Life (HRQoL)	8 weeks	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.
Health care utilization form	8 weeks	This will be used to measure direct health care costs and patient/family out of pocket costs related to arthritis care
Health Utility Index	8 weeks	Used to calculate quality adjusted life years (QALYs)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada