Clinical trial NCT02764346: iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
Official title: iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Arthritis
Self-management
Pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: British Columbia Children's Hospital
First posted: 2016-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

1. Aged 12-18 years
2. Diagnosed with JIA (36) as per their rheumatologist
3. Able to speak and read English
4. Have self-reported average arthritis-related pain in the past week of \>3 on 10cm visual analogue scale (VAS)
5. Willing to complete online study outcome measures

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

Primary outcomes:
measure: Participant accrual rate
timeFrame: 8 weeks
measure: Number of issues or difficulties in implementing the intervention
timeFrame: 8 weeks
measure: Acceptability of intervention
timeFrame: 8 weeks
measure: Frequency of login per user
timeFrame: 8 weeks
measure: Adherence
timeFrame: 8 weeks
measure: Adverse Events
timeFrame: 8 weeks
measure: Participant dropout rate
timeFrame: 8 weeks
measure: Satisfaction of intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain
timeFrame: 8 weeks
measure: Pain-Related Activity Limitations
timeFrame: 8 weeks
measure: Pain coping
timeFrame: 8 weeks
measure: Health-Related Quality of Life (HRQoL)
timeFrame: 8 weeks
measure: Health care utilization form
timeFrame: 8 weeks
measure: Health Utility Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Lalloo C, Harris LR, Hundert AS, Berard R, Cafazzo J, Connelly M, Feldman BM, Houghton K, Huber A, Laxer RM, Luca N, Schmeling H, Spiegel L, Tucker LB, Pham Q, Davies-Chalmers CC, Stinson JN. The iCanCope pain self-management application for adolescents with juvenile idiopathic arthritis: a pilot randomized controlled trial. Rheumatology (Oxford). 2021 Jan 5;60(1):196-206. doi: 10.1093/rheumatology/keaa178.