Chitra Lalloo1,2, Lauren R Harris1, Amos S Hundert1, Roberta Berard3, Joseph Cafazzo2,4, Mark Connelly5, Brian M Feldman6, Kristin Houghton7, Adam Huber8, Ronald M Laxer6, Nadia Luca9, Heinrike Schmeling9, Lynn Spiegel6, Lori B Tucker7, Quynh Pham2,4, Cleo C Davies-Chalmers1, Jennifer N Stinson1,2,10. 1. Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario. 2. Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario. 3. Division of Rheumatology, Children's Hospital London Health Sciences Centre, London, Ontario. 4. Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, Ontario, Canada. 5. Division of Developmental and Behavioural Health, Children's Mercy Kansas City, Kansas City, MO, USA. 6. Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario. 7. Division of Rheumatology, BC Children's Hospital, Vancouver, British Columbia. 8. Division of Rheumatology, IWK Health Centre, Halifax, Nova Scotia. 9. Section of Pediatric Rheumatology, Alberta Children's Hospital, Calgary, Alberta. 10. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
Abstract
OBJECTIVES: To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support. METHODS: A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: 'low' (≤24%); 'low-moderate' (25-49%); 'high-moderate' (50-75%); or 'high' (76-100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat. RESULTS:Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life. CONCLUSION: The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02764346.
RCT Entities:
OBJECTIVES: To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support. METHODS: A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: 'low' (≤24%); 'low-moderate' (25-49%); 'high-moderate' (50-75%); or 'high' (76-100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat. RESULTS: Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life. CONCLUSION: The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02764346.
Authors: Lauretta E Grau; Kaitlyn Larkin; Chitra Lalloo; Jennifer N Stinson; William T Zempsky; Samuel A Ball; Frank D Buono Journal: BMJ Open Date: 2022-07-15 Impact factor: 3.006
Authors: Richard Gordon-Williams; Andreia Trigo; Paul Bassett; Amanda Williams; Stephen Cone; Martin Lees; Brigitta Brandner Journal: Pain Res Manag Date: 2021-04-02 Impact factor: 3.037
Authors: Frank D Buono; Chitra Lalloo; Kaitlyn Larkin; William T Zempsky; Samuel Ball; Lauretta E Grau; Quynh Pham; Jennifer Stinson Journal: Contemp Clin Trials Commun Date: 2021-12-31
Authors: Alexandra Turnbull; Dean Sculley; Derek Santos; Mohammed Maarj; Lachlan Chapple; Xavier Gironès; Antoni Fellas; Andrea Coda Journal: Med Sci (Basel) Date: 2022-01-25
Authors: Carlton Dampier; Jennifer Stinson; Tonya M Palermo; Chitra Lalloo; Fareha Nishat; William Zempsky; Nitya Bakshi; Sherif Badawy; Yeon Joo Ko Journal: J Med Internet Res Date: 2022-08-30 Impact factor: 7.076
Authors: Aarushi Gupta; Joseph A Cafazzo; Maarten J IJzerman; Joost F Swart; Sebastiaan Vastert; Nico M Wulffraat; Susanne Benseler; Deborah Marshall; Rae Yeung; Marinka Twilt Journal: J Med Internet Res Date: 2021-12-24 Impact factor: 5.428
Authors: Sonia Butler; Dean Sculley; Derek Santos; Antoni Fellas; Xavier Gironès; Davinder Singh-Grewal; Andrea Coda Journal: J Med Internet Res Date: 2022-02-02 Impact factor: 5.428