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| Name | Class |
|---|---|
| Alberta Children's Hospital | OTHER |
| British Columbia Children's Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCanCope app | Experimental | iCanCope app |
|
| Attention control app | Active Comparator | Control group: iCanCope attention control app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32613229 | Derived | 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. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D001168 | Arthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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|
| 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. |
|
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 |
| 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. | 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. | 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. | 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 | 8 weeks |
| Health Utility Index | Used to calculate quality adjusted life years (QALYs) | 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |