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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iCanCope app
iCanCope attention control app
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Arthritis, Self-management, Pain

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iCanCope app

Attention control app

Arm Description

iCanCope app

Control group: iCanCope attention control app

Outcomes

Primary Outcome Measures

Participant accrual rate
Centrally tracked by the clinical research project coordinator
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.
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.
Frequency of login per user
Measured through the iCanCope server.
Adherence
Adherence will be determined using Google Analytics.
Adverse Events
Adverse events will be tracked using an adverse event form
Participant dropout rate
Centrally tracked by clinical research project coordinator
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.

Secondary Outcome Measures

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.
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.
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.
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.
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
Health Utility Index
Used to calculate quality adjusted life years (QALYs)

Full Information

First Posted
April 27, 2016
Last Updated
April 17, 2020
Sponsor
The Hospital for Sick Children
Collaborators
Alberta Children's Hospital, British Columbia Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02764346
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Alberta Children's Hospital, British Columbia Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Arthritis, Self-management, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCanCope app
Arm Type
Experimental
Arm Description
iCanCope app
Arm Title
Attention control app
Arm Type
Active Comparator
Arm Description
Control group: iCanCope attention control app
Intervention Type
Behavioral
Intervention Name(s)
iCanCope app
Intervention Description
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
Intervention Name(s)
iCanCope attention control app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant accrual rate
Description
Centrally tracked by the clinical research project coordinator
Time Frame
8 weeks
Title
Number of issues or difficulties in implementing the intervention
Description
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.
Time Frame
8 weeks
Title
Acceptability of intervention
Description
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.
Time Frame
8 weeks
Title
Frequency of login per user
Description
Measured through the iCanCope server.
Time Frame
8 weeks
Title
Adherence
Description
Adherence will be determined using Google Analytics.
Time Frame
8 weeks
Title
Adverse Events
Description
Adverse events will be tracked using an adverse event form
Time Frame
8 weeks
Title
Participant dropout rate
Description
Centrally tracked by clinical research project coordinator
Time Frame
8 weeks
Title
Satisfaction of intervention
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
8 weeks
Title
Pain-Related Activity Limitations
Description
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.
Time Frame
8 weeks
Title
Pain coping
Description
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.
Time Frame
8 weeks
Title
Health-Related Quality of Life (HRQoL)
Description
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.
Time Frame
8 weeks
Title
Health care utilization form
Description
This will be used to measure direct health care costs and patient/family out of pocket costs related to arthritis care
Time Frame
8 weeks
Title
Health Utility Index
Description
Used to calculate quality adjusted life years (QALYs)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32613229
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.
Results Reference
derived

Learn more about this trial

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

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