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Completed

NCT Number: NCT02764346

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

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Participant accrual rate

    Time frame: 8 weeks

    Centrally tracked by the clinical research project coordinator

  2. Number of issues or difficulties in implementing the intervention

    Time frame: 8 weeks

    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.

  3. Acceptability of intervention

    Time frame: 8 weeks

    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.

  4. Frequency of login per user

    Time frame: 8 weeks

    Measured through the iCanCope server.

  5. Adherence

    Time frame: 8 weeks

    Adherence will be determined using Google Analytics.

  6. Adverse Events

    Time frame: 8 weeks

    Adverse events will be tracked using an adverse event form

  7. Participant dropout rate

    Time frame: 8 weeks

    Centrally tracked by clinical research project coordinator

  8. Satisfaction of intervention

    Time frame: 8 weeks

    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 outcomes

  1. Pain

    Time frame: 8 weeks

    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.

  2. Pain-Related Activity Limitations

    Time frame: 8 weeks

    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.

  3. Pain coping

    Time frame: 8 weeks

    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.

  4. Health-Related Quality of Life (HRQoL)

    Time frame: 8 weeks

    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.

  5. Health care utilization form

    Time frame: 8 weeks

    This will be used to measure direct health care costs and patient/family out of pocket costs related to arthritis care

  6. Health Utility Index

    Time frame: 8 weeks

    Used to calculate quality adjusted life years (QALYs)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Alberta Children's Hospital
  • British Columbia Children's Hospital

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 6, 2016
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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