Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764346
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : April 20, 2020
Sponsor:
Collaborators:
Alberta Children's Hospital
British Columbia Children's Hospital
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date April 20, 2020
Study Start Date  ICMJE July 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
Official Title  ICMJE iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: iCanCope app
    iCanCope app
    Intervention: Behavioral: iCanCope app
  • Active Comparator: Attention control app
    Control group: iCanCope attention control app
    Intervention: Behavioral: iCanCope attention control app
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764346
Other Study ID Numbers  ICMJE 1000049274
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Stinson, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE
  • Alberta Children's Hospital
  • British Columbia Children's Hospital
Investigators  ICMJE Not Provided
PRS Account The Hospital for Sick Children
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP