An interventional study of iCanCope app and iCanCope attention control app in Juvenile Idiopathic Arthritis, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iCanCope app
Behavioral: iCanCope app
Control group: iCanCope attention control app
Behavioral: iCanCope attention control 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.
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.
Participant accrual rate
Centrally tracked by the clinical research project coordinator
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Frequency of login per user
Measured through the iCanCope server.
Time frame: 8 weeks
Adherence
Adherence will be determined using Google Analytics.
Time frame: 8 weeks
Adverse Events
Adverse events will be tracked using an adverse event form
Time frame: 8 weeks
Participant dropout rate
Centrally tracked by clinical research project coordinator
Time frame: 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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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
Time frame: 8 weeks
Health Utility Index
Used to calculate quality adjusted life years (QALYs)
Time frame: 8 weeks
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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