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

NCT02764346 | Completed

• 1 other identifier: 1000049274
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Arthritis; Self-management; Pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Pain

  8 weeks

• Pain-Related Activity Limitations

  8 weeks

• Pain coping

  8 weeks

• Health-Related Quality of Life (HRQoL)

  8 weeks

• Health care utilization form

  8 weeks

Study Arms (2)

iCanCope app

EXPERIMENTAL

iCanCope app

Behavioral: iCanCope app

Attention control app

ACTIVE COMPARATOR

Control group: iCanCope attention control app

Behavioral: iCanCope attention control app

Interventions

iCanCope app 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.

iCanCope app

iCanCope attention control app 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.

Attention control app

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Alberta Children's Hospital: collaborator
• British Columbia Children's Hospital: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 32613229 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/NP

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 6, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

CA (1)