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

NCT ID: NCT03715595

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-06-29

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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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SSDM group

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

Group Type EXPERIMENTAL

SSDM group

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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control group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Peking University International Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Dongguan donghua hospital

UNKNOWN

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Hebei General Hospital

OTHER

Sponsor Role collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of BaoTou Medical College

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Mianyang Central Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

Tianjin First Central Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun Li, doctor

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Chun Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhanguo Li, Doctor

Role: CONTACT

86-10-88324178

Facility Contacts

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Chun Li, Doctor

Role: primary

8610-13811190098

Zhanguo Li, Doctor

Role: backup

8610-13910713924

References

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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.

Reference Type RESULT
PMID: 19036778 (View on PubMed)

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.

Reference Type RESULT
PMID: 26290587 (View on PubMed)

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.

Reference Type RESULT
PMID: 24872377 (View on PubMed)

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.

Reference Type RESULT
PMID: 8948295 (View on PubMed)

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.

Reference Type RESULT
PMID: 19382860 (View on PubMed)

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.

Reference Type RESULT
PMID: 18615186 (View on PubMed)

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.

Reference Type RESULT
PMID: 25903352 (View on PubMed)

Li C, Huang J, Wu H, Li F, Zhao Y, Zhang Z, Li S, Wei H, Zhang M, Sun H, Yang J, Li Q, Li X, Qi W, Wei W, Li Y, Li Z, Wang Y, Zhang F, Wu H, Shuai Z, Wu Z, Li Y, Jia S, Jia Y, Xiao F, Mu R, Li Z. Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238343. doi: 10.1001/jamanetworkopen.2023.8343.

Reference Type DERIVED
PMID: 37058302 (View on PubMed)

Other Identifiers

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2018PHB065-01

Identifier Type: -

Identifier Source: org_study_id

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