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Juvenile Idiopathic ArthritisNCT02764346

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

A study testing iCanCope app in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
iCanCope app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Jul 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

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.

Being tested
iCanCope app, iCanCope attention control app
Keywords
Arthritis, Self-management, Pain
Medical subject headings
Arthritis, Juvenile, Arthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCanCope appBehavioural

    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 attention control appBehavioural

    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.

Study groups in NCT02764346
Study groupRoleWhat they receive
iCanCope appExperimentaliCanCope app
Receives: Behavioral: iCanCope app
Attention control appActive comparatorControl group: iCanCope attention control app
Receives: Behavioral: iCanCope attention control app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant accrual rate

    Centrally tracked by the clinical research project coordinator

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. Frequency of login per user

    Measured through the iCanCope server.

    Measured: 8 weeks

  5. Adherence

    Adherence will be determined using Google Analytics.

    Measured: 8 weeks

  6. Adverse Events

    Adverse events will be tracked using an adverse event form

    Measured: 8 weeks

  7. Participant dropout rate

    Centrally tracked by clinical research project coordinator

    Measured: 8 weeks

  8. 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.

    Measured: 8 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

  5. 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

    Measured: 8 weeks

  6. Health Utility Index

    Used to calculate quality adjusted life years (QALYs)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02764346
Sponsor's protocol ID
1000049274
Status last verified
Apr 2020
First submitted
27 Apr 2016
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32613229

Questions about this trial

What is this clinical trial studying?

A study testing iCanCope app in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant accrual rate (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02764346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.

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