The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)

Rheumatoid Arthritis Clinical Trial

— T2TRAonSSDM  

Official title:

The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715595
• Other study ID #: 2018PHB065-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 29, 2020

Study information

• Verified date: June 2020
• Source: Peking University People's Hospital
• Contact: Zhanguo Li, Doctor
• Phone: 86-10-88324178
• Email: fiona_leechun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.

Description:

Treat-to-Target (T2T), achieving a DAS28 score lower than 2.6 (remission, Rem) or below 3.2 (low disease activity, LDA), is the main management strategy recommended by ACR and EULAR. The Smart System of Disease Management (SSDM) is an interactive mobile disease management tool, including the doctors' and patients' application system. The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) through the mobile application. The data synchronizes to the mobiles of authorized rheumatologists through cloud data base and advices could be delivered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: June 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of Rheumatoid Arthritis.

2. Have a smartphone

3. Must be able to access disease activity by themselves

Exclusion Criteria:

1. Not able to access disease activity by themselves

2. Lacks the ability of self-management

3. Mental disorders or severe physical dysfunction

4. Extremely poor compliance

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• SSDM group
The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) every month.

Locations

Country	Name	City	State
China	Chun Li	Beijing	Beijing

Sponsors (23)

Lead Sponsor

Collaborator

Peking University People's Hospital

Anhui Provincial Hospital, Bethune International Peace Hospital, Central South University, Dongguan donghua hospital, First Hospital of China Medical University, Hebei General Hospital, Linyi People's Hospital, Mianyang Central Hospital, Peking University International Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shandong Provincial Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Subei People's Hospital of Jiangsu Province, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of BaoTou Medical College, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Yunnan, Tianjin First Central Hospital, Tianjin Medical University General Hospital, Xijing Hospital, Xuanwu Hospital, Beijing, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296- — View Citation

Barlow J, Turner A, Swaby L, Gilchrist M, Wright C, Doherty M. An 8-yr follow-up of arthritis self-management programme participants. Rheumatology (Oxford). 2009 Feb;48(2):128-33. doi: 10.1093/rheumatology/ken429. Epub 2008 Nov 26. — View Citation

Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, — View Citation

Harrison BJ, Symmons DP, Brennan P, Barrett EM, Silman AJ. Natural remission in inflammatory polyarthritis: issues of definition and prediction. Br J Rheumatol. 1996 Nov;35(11):1096-100. Review. — View Citation

Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099. Review. — View Citation

Marshall A, Medvedev O, Antonov A. Use of a smartphone for improved self-management of pulmonary rehabilitation. Int J Telemed Appl. 2008:753064. doi: 10.1155/2008/753064. — View Citation

McBain H, Shipley M, Olaleye A, Moore S, Newman S. A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial. Ann Rheum Dis. 2016 Jul;75(7):1343-9. doi: 10.1136/annrh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of T2T between the two groups.	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group.	six month
Secondary	The rate of T2T between the two groups.	Self-reported data was reported every month until the twelve month in the two groups	twelve month
Secondary	The relapse rate between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The safety of drug use between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The compliance between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The HADS between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The SF-36 between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The medical economics between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The numbers of active intervention by doctors between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month
Secondary	The effect of active intervention by doctors between the two groups	Self-reported data was reported at baseline and every month until the sixth month in the SSDM group and the patients only reported their disease at baseline and the sixth month in the control group. After 6 months, all the patients will use the SSDM for 6 months.	Six month and twelve month