Rheumatoid Arthritis
Conditions
Keywords
treat-to-target, smart system of disease management, drug use
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.
Interventions
OTHERSSDM 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.
Sponsors
Anhui Provincial Hospital
The First Affiliated Hospital of Anhui Medical University
Peking University International Hospital
Xuanwu Hospital, Beijing
Dongguan donghua hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Hebei General Hospital
Bethune International Peace Hospital
Central South University
The First Affiliated Hospital with Nanjing Medical University
Subei People's Hospital of Jiangsu Province
The First Affiliated Hospital of BaoTou Medical College
Linyi People's Hospital
Shandong Provincial Hospital
Mianyang Central Hospital
Tianjin Medical University General Hospital
The First People's Hospital of Yunnan
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Provincial People's Hospital
First Hospital of China Medical University
Xijing Hospital
Tianjin First Central Hospital
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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. |
Countries
China
Contacts
Primary ContactZhanguo Li, Doctor
Outcome results
None listed