Clinical trial NCT03715595: The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)
Official title: The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: treat-to-target
smart system of disease management
drug use
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Anhui Provincial Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Peking University International Hospital
name: Xuanwu Hospital, Beijing
name: Dongguan donghua hospital
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Hebei General Hospital
name: Bethune International Peace Hospital
name: Central South University
name: The First Affiliated Hospital with Nanjing Medical University
name: Subei People's Hospital of Jiangsu Province
name: The First Affiliated Hospital of BaoTou Medical College
name: Linyi People's Hospital
name: Shandong Provincial Hospital
name: Mianyang Central Hospital
name: Tianjin Medical University General Hospital
name: The First People's Hospital of Yunnan
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhejiang Provincial People's Hospital
name: First Hospital of China Medical University
name: Xijing Hospital
name: Tianjin First Central Hospital
First posted: 2018-10-23
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of T2T between the two groups.
timeFrame: six month
Secondary outcomes:
measure: The rate of T2T between the two groups.
timeFrame: twelve month
measure: The relapse rate between the two groups
timeFrame: Six month and twelve month
measure: The safety of drug use between the two groups
timeFrame: Six month and twelve month
measure: The compliance between the two groups
timeFrame: Six month and twelve month
measure: The HADS between the two groups
timeFrame: Six month and twelve month
measure: The SF-36 between the two groups
timeFrame: Six month and twelve month
measure: The medical economics between the two groups
timeFrame: Six month and twelve month
measure: The numbers of active intervention by doctors between the two groups
timeFrame: Six month and twelve month
measure: The effect of active intervention by doctors between the two groups
timeFrame: Six month and twelve month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chun Li
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Chun Li, doctor
role: STUDY_DIRECTOR
References:
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