iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
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|ClinicalTrials.gov Identifier: NCT02764346|
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Behavioral: iCanCope app Behavioral: iCanCope attention control app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: iCanCope app
Behavioral: iCanCope 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.
Active Comparator: Attention control app
Control group: iCanCope attention control app
Behavioral: iCanCope attention control app
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 [ Time Frame: 8 weeks ]Centrally tracked by the clinical research project coordinator
- 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.
- 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.
- Frequency of login per user [ Time Frame: 8 weeks ]Measured through the iCanCope server.
- Adherence [ Time Frame: 8 weeks ]Adherence will be determined using Google Analytics.
- Adverse Events [ Time Frame: 8 weeks ]Adverse events will be tracked using an adverse event form
- Participant dropout rate [ Time Frame: 8 weeks ]Centrally tracked by clinical research project coordinator
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Health Utility Index [ Time Frame: 8 weeks ]Used to calculate quality adjusted life years (QALYs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764346
|Contact: Jennifer N Stinson, RN, PhD||416-813-7654 ext firstname.lastname@example.org|
|Contact: Chitra Lalloo, BHSc, PhD||416-813-7654 ext email@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Lauren Harris, MSc(OT) 416-813-7654 ext 302314 firstname.lastname@example.org|
|Principal Investigator: Jennifer Stinson, RN-EC, PhD, CPNP|