Older age and low literacy were not barriers to self-monitoring and reporting disease activity.
Patients with rheumatoid arthritis (RA) who reported clinical information via an app had an increased rate of disease control, according to a multicenter study recently published in JAMA Network Open.
A common treatment approach in RA, a chronic inflammatory disease, treat to target, which sets specific disease management goals and monitors progress in achieving them. The process calls for standardized assessment that includes objective and subjective evaluations.
“There is a need for the patient to participate in disease management not only in treatment decision making but also in disease activity assessment,” the authors said.
Patient-reported outcomes typically include pain, impaired physical function, and other indications of increasing disease activity. Episodic remissions and flares may also be reported.
A 28-joint disease activity score (DAS28) is a tool often used for monitoring RA disease activity. DAS28 scores are calculated using specific health status indices, such as swollen and tender joints. In addition, clinicians may order blood tests—such as erythrocyte sedimentation rate and C-reactive protein (CRP)—to gauge the extent of inflammation occurring throughout the body.
To monitor the severity of RA in study participants, the study investigators used DAS28 and CRP (DAS28-CRP).
Their open-label randomized clinical trial enrolled 2197 patients at 22 tertiary hospitals across China. All patients (mean [SD] age, 50.5 [12.4] years; 82.5%, female) were followed for 12 months. The study consisted of an initial 6-month phase that compared a smart system of disease (SSDM) and conventional medical care. Half of the participants each were randomly assigned to SSDM or conventional care. In a 6-month extension phase, patients in both groups used SSDM management.
Randomization was stratified based on severity of disease. At baseline, a DAS28-CRP score of 2.6 or represented remission, 2.6 to 3.2 represented low disease activity (LDA), 3.2 to 5.1 represented moderate disease activity (MDA), and above 5.1 represented high disease activity (HDA)
The primary end point was the rate of patients with a DAS28-CRP of 3.2 or less at month 6.
Researchers trained participants on key SSDM features so they could correctly use the application. SSDM participants assessed/reported on their condition monthly. They uploaded their DAS28-CRP score and other indications of disease fluctuation, such as laboratory results, medications, and perceived adverse reactions. Rheumatologists could review the data and provide instructions, adjust or prescribe medications, or request an outpatient visit.
Meanwhile, the study investigators monitored SSDM group adherence, defined as the ratio of actual self-assessment numbers against the required self-assessment numbers. Adherence to the research protocol was 96.5%.
Four months into the trial, the researchers activated an alert function in the SSDM system. Red flags, with targets set according to patients’ severity of disease activity at baseline, were highlighted for review. Abnormal laboratory results could trigger an alert as well.
Additionally, the researchers reviewed adverse events as reported by rheumatologists or resulting from alerts. None of the adverse events was related to the use of a digital health application.
Findings from the study showed a higher rate of DAS28-CRP score of 3.2 or less at the 6-month mark in the SSDM group, regardless of age, sex, or education: 71.0% vs 64.5% in the control group. This led the authors to suggest that older age and low educational level were not significant barriers to using SSMD. At the 12-month mark, the rate in the SSDM group had increased to 78.2%.
Interestingly, the study dropout rate in the SSDM group was 11.9% vs 19.3% in the control group. The authors speculated that the difference in attrition may have biased their results.
Still, by the 12-month mark, the rate of patients with a DAS28-CRP score of 3.2 or less in the control group, using SSDM during the 6-month extension phase, had increased to 77.7%, a finding comparable to the SSDM group.
“The app-based alert and intervention allow physicians to be aware of the need for prompt intervention and motivate patients to manage their disease,” the authors concluded.
Li C, Huang J, Wu H, at al. Management of rheumatoid arthritis with a digital health application, a multicenter, pragmatic randomized clinical trial. JAMANetwork Open. Published online April 3, 2023. doi:10.1001/jamanetworkopen.2023.8343