CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT The abstract includes a description about the type of manipulation "Objectives: The aim was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity, health care utilization, medication overuse, empowerment and RA knowledge of RA patients. The effect of gamification on website use was also investigated. Methods: We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino (Italian-speaking part of Switzerland). The 157 recruited patients through brochures left with physician were randomly allocated to one of the 4 experimental conditions corresponding to different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through online questionnaires and a paper-pencil version for the control group at baseline, posttest 2 months later and a follow-up after another 2 months. " 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT There was no direct physician/therapist involvement (face-to-face or by telephone) during the intervention. The intervention included as part of the experimental manipulation pre-scheduled chat-room sessions that were moderated by the research team and involved the synchronous interaction between the patients and the doctors through the website. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "The 157 recruited patients through brochures left with physician were randomly allocated to one of the 4 experimental conditions corresponding to different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through online questionnaires and a paper-pencil version for the control group at baseline, posttest 2 months later and a follow-up after another 2 months. " 1b-iv) RESULTS section in abstract must contain use data The results section included the analysis of the RCT and reported the estimated parameters with their corresponding p-values. "The best-fit multilevel models (growth curve models) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors. The growth curve analyses of experimental conditions were always in comparison with the control group. Physical activity (amount spent on exercise) increased over time for patients having access to social support sections and gaming (unstandardized beta coefficient [B] =3.39, P=.02). The rate of change in health care utilization showed a significant decrease for patients accessing social support features (B=-.41, P=.01) and patients accessing both social support features and gaming (B=-.33, P=.03). Moreover, patients who had access to social support features witnessed a significant decrease rate of medication overuse (B=-1.61, P=.05). Patients who had access to either social support sections or the gaming experience of the website gained more empowerment (B=2.59, P=.03) (B=2.29, P=.05) respectively. Lastly, patients who were offered gamified experience used the website more often than the ones who were deprived from (t(91) = -2.27 P=.02) (U=812, P=.02). " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials The intervention did not have negative consequences or effects on patients. Therefore item 1b-v is not applicable. INTRODUCTION 2a-i) Problem and the type of system/solution "The intervention used in this study is “ONESELF”, a Web-based intervention designed and operated for chronically ill patients with rheumatoid arthritis (RA). RA is a chronic systemic disease that affects the joints, connective tissues, muscles, tendons, and fibrous tissue [40]. Adults between the ages of 20-40 are predominantly targeted by the disease, which is more prevalent in women than in men [40]. Since, in terms of economics, RA affects people during an especially productive period of their lives, it is globally considered a serious public health problem. In Switzerland up to 1% of the population suffers from RA where its estimated cost on the Swiss society reaches 23,982 euros per patient a year [41]. The impact of RA goes beyond physical and economic aspects; it affects patients psychologically and emotionally, making them suffer severe consequences and losses [42]. ONESELF has informational and online support features and a gamified user experience, but access to these features was manipulated for the different experimental groups. We developed ONESELF in collaboration with the doctors of the Swiss Rheumatology Association (www.oneself.ch). ONESELF started in 2004 (early prototype and development) and pursued the aim of helping patients with chronic low back pain and fibromyalgia syndrome (FMS) to enhance their self-management and better cope with their conditions [43-47]. " 2a-ii) Scientific background, rationale: What is known about the (type of) system