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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 : July 19, 2018
Sponsor:
Collaborators:
Alberta Children's Hospital
British Columbia Children's Hospital
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iCanCope app
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jennifer N Stinson, RN, PhD 416-813-7654 ext 304514 jennifer.stinson@sickkids.ca
Contact: Chitra Lalloo, BHSc, PhD 416-813-7654 ext 302332 chitra.lalloo@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Lauren Harris, MSc(OT)    416-813-7654 ext 302314    lauren.harris@sickkids.ca   
Principal Investigator: Jennifer Stinson, RN-EC, PhD, CPNP         
Sponsors and Collaborators
The Hospital for Sick Children
Alberta Children's Hospital
British Columbia Children's Hospital

Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02764346     History of Changes
Other Study ID Numbers: 1000049274
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
Arthritis
Self-management
Pain

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases