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
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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UNKNOWN
NA
2200 participants
INTERVENTIONAL
2018-11-01
2020-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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SSDM group
The patients in will use the SSDM at home every month for one year.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a smartphone
3. Must be able to access disease activity by themselves
Exclusion Criteria
2. Lacks the ability of self-management
3. Mental disorders or severe physical dysfunction
4. Extremely poor compliance
18 Years
ALL
No
Sponsors
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Anhui Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Anhui Medical University
OTHER
Peking University International Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
Dongguan donghua hospital
UNKNOWN
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Hebei General Hospital
OTHER
Bethune International Peace Hospital
OTHER
Central South University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Subei People's Hospital of Jiangsu Province
OTHER
The First Affiliated Hospital of BaoTou Medical College
OTHER
Linyi People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Mianyang Central Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Zhejiang Provincial People's Hospital
OTHER
First Hospital of China Medical University
OTHER
Xijing Hospital
OTHER
Tianjin First Central Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2018PHB065-01
Identifier Type: -
Identifier Source: org_study_id
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