The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM) (T2TRAonSSDM)

Peking University

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Other: SSDM group

Study type: Interventional

Funder types: Other

Identifiers

NCT03715595

2018PHB065-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,200 participants in 2 patient groups

SSDM group

Experimental group

Description:

The patients in will use the SSDM at home every month for one year.

Treatment:

Other: SSDM group

Control group

No Intervention group

Description:

The patients will receive the conventional therapy for half a year. After half a year, all the patients will use the SSDM at home monthly for half a year.