Management of Rheumatoid Arthritis With a Digital Health Application

Author:

Li Chun1,Huang Jianlin2,Wu Huaxiang3,Li Fen4,Zhao Yi5,Zhang Zhenchun6,Li Shengguang7,Wei Hua8,Zhang Miaojia9,Sun Hongsheng10,Yang Jing11,Li Qin12,Li Xiaomei13,Qi Wufang14,Wei Wei15,Li Yasong16,Li Zhenbin17,Wang Yongfu18,Zhang Fengxiao19,Wu Henglian20,Shuai Zongwen21,Wu Zhenbiao22,Li Yi23,Jia Shengsong24,Jia Yuhua24,Xiao Fei24,Mu Rong25,Li Zhanguo12627

Affiliation:

1. Department of Rheumatology and Immunology, Peking University People’s Hospital, Beijing, China

2. Department of Rheumatology, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

3. Department of Rheumatology and Immunology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

4. Department of Rheumatology and Immunology, the Second Xiangya Hospital of Central South University, Changsha, Hunan, China

5. Department of Rheumatology and Immunology, Xuanwu Hospital Capital Medical University, Beijing, China

6. Department of Rheumatology and Immunology, Linyi People’s Hospital, Linyi, Shandong, China

7. Department of Rheumatology and Immunology, Peking University International Hospital, Zhongguancun Life Science Park, Beijing, China

8. Department of Rheumatology and Immunology, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China

9. Department of Rheumatology and Immunology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

10. Department of Rheumatology and Immunology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China

11. Department of Rheumatology and Immunology, Mianyang Central Hospital, Mianyang, Sichuan, China

12. Department of Rheumatology and Immunology, the First People's Hospital of Yunnan Province, Kunming, Yunnan, China

13. Department of Rheumatology and Immunology, the First Affiliated Hospital of USTC, Hefei, Anhui, China

14. Department of Rheumatology and Immunology, Tianjin First Central Hospital, Tianjin, China

15. Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China

16. Department of Rheumatology and Immunology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, China

17. Department of Rheumatology and Immunology, Bethune International Peace Hospital, Shijiazhuang, Hebei, China

18. Department of Rheumatology and Immunology, the First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China

19. Department of Rheumatology and Immunology, Hebei General Hospital, Shijiazhuang, Hebei, China.

20. Department of Rheumatology and Immunology, Tungwah Hospital of Sun Yat-sen University, Dongguan, Guangdong, China

21. Department of Rheumatology and Immunology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

22. Department of Rheumatology and Immunology, Xijing Hospital, Xi'an, Shanxi, China

23. School of Statistics and Mathematics, Nanjing Audit university, Nanjing, Jiangsu, China

24. Shanghai Gothic Internet Technology Co, Shanghai, China

25. Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing, China

26. State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, Beijing, China.

27. Peking-Tsinghua Center for Life Sciences, Peking University, Beijing, China

Abstract

IMPORTANCEDigital health applications have been shown to be effective in the management of chronic diseases with simple treatment targets. The potential clinical value of digital health applications in rheumatoid arthritis (RA) has not been well studied.OBJECTIVETo investigate whether assessing patient-reported outcomes using digital health applications could result in disease control for patients with RA.DESIGN, SETTING, AND PARTICIPANTSThis is a multicenter, open-label randomized clinical trial in 22 tertiary hospitals across China. Eligible participants were adult patients with RA. Participants were enrolled from November 1, 2018, to May 28, 2019, with a 12-month follow-up. The statisticians and rheumatologists who assessed disease activity were blinded. Investigators and participants were not blind to group assignment. Analysis was conducted from October 2020 to May 2022.INTERVENTIONSParticipants were randomly assigned at a 1:1 ratio (block size of 4) to a smart system of disease management group (SSDM) or a conventional care control group. Upon the completion of the 6-month parallel comparison, patients in the conventional care control group were instructed to use the SSDM application for an extension of 6 months.MAIN OUTCOMES AND MEASURESThe primary outcome was the rate of patients with disease activity score in 28 joints using the C-reactive protein (DAS28-CRP) of 3.2 or less at month 6.RESULTSOf 3374 participants screened, 2204 were randomized, and 2197 patients with RA (mean [SD] age, 50.5 [12.4] years; 1812 [82.5%] female) were enrolled. The study included 1099 participants in the SSDM group and 1098 participants in the control group. At month 6, the rate of patients with DAS28-CRP of 3.2 or less was 71.0% (780 of 1099 patients) in the SSDM group vs 64.5% (708 of 1098 patients) in the control group (difference between groups, 6.6%; 95% CI, 2.7% to 10.4%; P = .001). At month 12, the rate of patients with DAS28-CRP of 3.2 or less in the control group increased to a level (77.7%) that was comparable with that (78,2%) in the SSDM group (difference between groups, −0.2%; 95% CI, −3.9% to 3.4%; P = .90).CONCLUSIONS AND RELEVANCEIn this randomized clinical trial of RA, the use of a digital health application with patient-reported outcomes was associated with an increase in disease control rate.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT03715595

Publisher

American Medical Association (AMA)

Subject

General Medicine

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