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

NCT ID: NCT02764346

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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iCanCope app

iCanCope app

Group Type EXPERIMENTAL

iCanCope app

Intervention Type BEHAVIORAL

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.

Attention control app

Control group: iCanCope attention control app

Group Type ACTIVE_COMPARATOR

iCanCope attention control app

Intervention Type BEHAVIORAL

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.

Interventions

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iCanCope app

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.

Intervention Type BEHAVIORAL

iCanCope attention control app

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Children's Hospital

OTHER

Sponsor Role collaborator

British Columbia Children's Hospital

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/NP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32613229 (View on PubMed)

Other Identifiers

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1000049274

Identifier Type: -

Identifier Source: org_study_id

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