Digital health applications using patient-reported outcomes (PROs) may be effective in disease treatment and control among patients with rheumatoid arthritis (RA), according to the results of a multicenter open-label randomized trial published in JAMA Network Open.
The effectiveness of digital health applications among patients with RA has been unclear.
Researchers aimed to assess the use of digital health applications that report PROs among patients with RA and their effects on disease control.
The study was performed in 22 hospitals throughout China. Adults with RA who met the criteria for the 2010 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) were randomly assigned 1:1 into the smart system of disease management (SSDM) group or the conventional care group.
The SSDM group reported self-assessments once per month for 12 months, while the control group received conventional care and routine visits for 6 months, with follow-up visits at 6 and 12 months. Patients in the control group were also asked to use the digital health application, following an initial 6-month parallel comparison.
The primary study outcome was the rate of patients with a disease activity score in 28 joints using C-reactive protein (DAS28-CRP) of 3.2 or less at 6 months. Secondary outcomes included number of patients with moderate to good EULAR response rates and number of adverse events reported.
A total of 2197 patients were included in the study (1099 patients in the SSDM group and 1098 patients in the control group). Mean age of study participants was 50.5 years and the majority of patients were women (82.5%). Mean adherence to SSDM reporting was 96.5%.
At 6 months, 71.0% of patients in the SSDM group had a DAS28-CRP score of 3.2 or less compared with 64.5% of the control participants (difference between groups, 6.6%; P =.001). Rates of DAS28-CRP scores of 3.2 or lower for both groups continued to increase until 12 months, with the rate of patients at 78.2% and that of control participants at 77.7%.
Number of patients with DAS2-CRP scores of 3.2 or lower remained higher in the SSDM group, regardless of both age and educational status.
The SSDM vs control group reported higher moderate to good EULAR response rates (58.3% vs 52.8%; P =.01). No adverse events related to the use of the digital health application were reported.
The study was limited by differing rates of attrition between groups, which may have caused bias. In addition, whether patient patient-reported assessment without laboratory testing could be used in digital health applications for clinical practice was unclear.
In accordance with recent health crises, the study authors noted, “The findings in this trial are also important in an era of novel public health threats exemplified by the ongoing COVID-19 pandemic and its impact on the behaviors of patients and physicians. Virtual visits or telemedicine need to be proven as effective as outpatient clinic visits in controlling the disease activity of RA.”
Li C, Huang J, Wu H, et al. Management of rheumatoid arthritis with a digital health application: a multicenter, pragmatic randomized clinical trial. JAMA Netw Open. 2023;6(4):e238343. doi:10.1001/jamanetworkopen.2023.8343