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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Other: SSDM group

• Registration Number: NCT03715595
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Primary Completion: 2020-05-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05
• Study Completion: 2020-06-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSDM group	SSDM group	The patients in will use the SSDM at home every month for one year.

Primary Outcome Measures

Name	Time	Method
The rate of T2T between the two groups.	six month	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.

Secondary Outcome Measures

Name	Time	Method
The rate of T2T between the two groups.	twelve month	Self-reported data was reported every month until the twelve month in the two groups
The relapse rate between the two groups	Six month and twelve month	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.
The safety of drug use between the two groups	Six month and twelve month	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.
The medical economics between the two groups	Six month and twelve month	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.
The numbers of active intervention by doctors between the two groups	Six month and twelve month	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.
The SF-36 between the two groups	Six month and twelve month	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.
The compliance between the two groups	Six month and twelve month	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.
The HADS between the two groups	Six month and twelve month	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.
The effect of active intervention by doctors between the two groups	Six month and twelve month	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.

Trial Locations

Locations (1)

Chun Li; 🇨🇳 Beijing, Beijing, China