A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis

Abstract

Objectives In RA, telemedicine may allow tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician’s interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA. Methods A six-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new DMARD therapy. Two groups were established: ‘connected monitoring’ and ‘conventional monitoring’. The primary outcome was the number of physical visits between baseline and six months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12). Results Of the 94 randomized patients, 89 completed study: 44 in the ‘conventional monitoring’ arm and 45 in the ‘connected monitoring’ arm. The total number of physical visits between required baseline and six-month visits was significantly lower in the ‘connected monitoring’ group [0.42 (0.58) vs 1.93 (0.55); P <0.05]. No differences between groups were observed in the clinical and functional scores. A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the ‘connected monitoring’ group. Conclusion Our results suggest that connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03005925.

The Challenges of Telemedicine in Rheumatology

“…In rheumatology, encouraging studies in tele-monitoring of RA have shown similar results in disease control compared to conventional monitoring (26,27). In our study, we demonstrated an improvement in quality of life in patients benefiting from tele-monitoring (18) as well as a reduction in costs (unpublished data). Patients also feel reassured because they are provided with alerts and information, especially in case of infection.…”

“…Recently, we developed a connected interface (SATIE PR) operating with the help of a project manager to provide remote monitoring in patients with active RA initiating a new disease-modifying therapy. Our randomized controlled trial showed that disease control with the connected interface was similar to that of conventional follow-up and that the number of physical visits was significantly reduced in the connected group after 6 months ( 18 ). It was also the first time that a connected monitoring application showed a positive effect on quality of life in RA ( 18 ).…”

“…Our randomized controlled trial showed that disease control with the connected interface was similar to that of conventional follow-up and that the number of physical visits was significantly reduced in the connected group after 6 months ( 18 ). It was also the first time that a connected monitoring application showed a positive effect on quality of life in RA ( 18 ). Indeed, use of telemedicine may optimize disease monitoring allowing that face-to-face time can be dedicated to more severe or complex patients.…”

The ideal mHealth-application for rheumatoid arthritis: qualitative findings from stakeholder focus groups

“…While it was suggested that the early stages of disease would therefore present the ideal window for mHealth-guided symptom-tracking, our results also show that a degree of experience in recognising disease symptoms appears crucial. Strikingly, while recent studies on mHealth-interventions have been very heterogeneous in nature, only one study has to date investigated an mHealth-guided intervention in patients with early or active disease [ 12 , 18 ]. Therefore, the ideal target population for an mHealth-application remains a matter of debate.…”

“…Specifically, remote monitoring of a well-selected set of patient-reported outcomes (PROs) and wearable-obtained physical parameters could provide continuous information on a patient’s health status [ 11 ]. Since the T2T-strategy implies a need for frequent assessment of treatment response, such a remote monitoring approach holds promise to predict the need for urgent clinic visits in patients with high disease activity, but also to reduce the number of clinical visits for well-controlled patients [ 12 ]. By consequence, remote monitoring of symptoms through mHealth-applications could present a possible cost-saving measure [ 13 ], even though the potential impact on quality of care warrants further investigation.…”