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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764346
• Other study ID #: 1000049274
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria

1. Aged 12-18 years

2. Diagnosed with JIA (36) as per their rheumatologist

3. Able to speak and read English

4. Have self-reported average arthritis-related pain in the past week of >3 on 10cm visual analogue scale (VAS)

5. Willing to complete online study outcome measures

Exclusion Criteria:

1. Moderate to severe cognitive impairments as per their healthcare provider

2. 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

3. Received more than 4 CBT sessions for pain management in the past 6 months, as per their healthcare provider and self-report

4. Patients from the department of haematology/oncology

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Alberta Children's Hospital, British Columbia Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant accrual rate	Centrally tracked by the clinical research project coordinator	8 weeks
Primary	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
Primary	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
Primary	Frequency of login per user	Measured through the iCanCope server.	8 weeks
Primary	Adherence	Adherence will be determined using Google Analytics.	8 weeks
Primary	Adverse Events	Adverse events will be tracked using an adverse event form	8 weeks
Primary	Participant dropout rate	Centrally tracked by clinical research project coordinator	8 weeks
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health Utility Index	Used to calculate quality adjusted life years (QALYs)	8 weeks