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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSDM group
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring treat-to-target, smart system of disease management, drug use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chun LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SSDM group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The rate of T2T between the two groups.
Self-reported data was reported every month until the twelve month in the two groups
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 4, 2018
Last Updated
June 4, 2020
Sponsor
Peking University People's Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03715595
Brief Title
The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)
Acronym
T2TRAonSSDM
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 29, 2020 (Anticipated)
Study Completion Date
June 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
treat-to-target, smart system of disease management, drug use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSDM group
Arm Type
Experimental
Arm Description
The patients in will use the SSDM at home every month for one year.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
SSDM group
Other Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of T2T between the two groups.
Description
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.
Time Frame
six month
Secondary Outcome Measure Information:
Title
The rate of T2T between the two groups.
Description
Self-reported data was reported every month until the twelve month in the two groups
Time Frame
twelve month
Title
The relapse rate between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The safety of drug use between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The compliance between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The HADS between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The SF-36 between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The medical economics between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The numbers of active intervention by doctors between the two groups
Description
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.
Time Frame
Six month and twelve month
Title
The effect of active intervention by doctors between the two groups
Description
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.
Time Frame
Six month and twelve month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhanguo Li, Doctor
Phone
86-10-88324178
Email
fiona_leechun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Li, doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chun Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Li, Doctor
Phone
8610-13811190098
Email
13811190098@163.com
First Name & Middle Initial & Last Name & Degree
Zhanguo Li, Doctor
Phone
8610-13910713924
Email
zgli99@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19036778
Citation
Barlow J, Turner A, Swaby L, Gilchrist M, Wright C, Doherty M. An 8-yr follow-up of arthritis self-management programme participants. Rheumatology (Oxford). 2009 Feb;48(2):128-33. doi: 10.1093/rheumatology/ken429. Epub 2008 Nov 26.
Results Reference
result
PubMed Identifier
26290587
Citation
McBain H, Shipley M, Olaleye A, Moore S, Newman S. A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial. Ann Rheum Dis. 2016 Jul;75(7):1343-9. doi: 10.1136/annrheumdis-2015-207768. Epub 2015 Aug 19.
Results Reference
result
PubMed Identifier
24872377
Citation
Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.
Results Reference
result
PubMed Identifier
8948295
Citation
Harrison BJ, Symmons DP, Brennan P, Barrett EM, Silman AJ. Natural remission in inflammatory polyarthritis: issues of definition and prediction. Br J Rheumatol. 1996 Nov;35(11):1096-100. doi: 10.1093/rheumatology/35.11.1096.
Results Reference
result
PubMed Identifier
19382860
Citation
Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
Results Reference
result
PubMed Identifier
18615186
Citation
Marshall A, Medvedev O, Antonov A. Use of a smartphone for improved self-management of pulmonary rehabilitation. Int J Telemed Appl. 2008;2008:753064. doi: 10.1155/2008/753064.
Results Reference
result
PubMed Identifier
25903352
Citation
Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296-015-3270-9. Epub 2015 Apr 24.
Results Reference
result

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

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