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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: SSDM group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Rheumatoid Arthritis. Have a smartphone Must be able to access disease activity by themselves Exclusion Criteria: Not able to access disease activity by themselves Lacks the ability of self-management Mental disorders or severe physical dysfunction Extremely poor compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSDM group<br>The patients in will use the SSDM at home every month for one year. | Other: SSDM group<br>* 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.<br>* Other names: control group;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treat-to-target, smart system of disease management, drug use