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

June 4, 2020 updated by: Peking University People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Chun Li
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SSDM group
The patients in will use the SSDM at home every month for one year.
Other: SSDM 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.
Other Names:
  • control group
NO_INTERVENTION: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of T2T between the two groups.
Time Frame: 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.
six month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Xijing Hospital
The First Affiliated Hospital of Anhui Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hebei General Hospital
Xuanwu Hospital, Beijing
Peking University International Hospital
Shandong Provincial Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Tianjin Medical University General Hospital
Central South University
First Hospital of China Medical University
Tianjin First Central Hospital
Zhejiang Provincial People's Hospital
Bethune International Peace Hospital
Anhui Provincial Hospital
Subei People's Hospital of Jiangsu Province
Mianyang Central Hospital
The First Affiliated Hospital of BaoTou Medical College
The First People's Hospital of Yunnan
Linyi People's Hospital
Dongguan donghua hospital

Investigators

  • Study Director: Chun Li, doctor, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ANTICIPATED)

May 29, 2020

Study Completion (ANTICIPATED)

June 29, 2020

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018PHB065-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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