Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT03715595
Status:
UNKNOWN
Last Update Posted:
2020-06-05
First Post:
2018-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of T2T between the two groups.', 'timeFrame': 'six month', '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.'}], 'secondaryOutcomes': [{'measure': 'The rate of T2T between the two groups.', 'timeFrame': 'twelve month', 'description': 'Self-reported data was reported every month until the twelve month in the two groups'}, {'measure': 'The relapse rate between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The safety of drug use between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The compliance between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The HADS between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The SF-36 between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The medical economics between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The numbers of active intervention by doctors between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}, {'measure': 'The effect of active intervention by doctors between the two groups', 'timeFrame': 'Six month and twelve month', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treat-to-target', 'smart system of disease management', 'drug use'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '19036778', 'type': 'RESULT', '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.'}, {'pmid': '26290587', 'type': 'RESULT', '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.'}, {'pmid': '24872377', 'type': 'RESULT', '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.'}, {'pmid': '8948295', 'type': 'RESULT', '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.'}, {'pmid': '19382860', 'type': 'RESULT', '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.'}, {'pmid': '18615186', 'type': 'RESULT', '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.'}, {'pmid': '25903352', 'type': 'RESULT', '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."}, {'pmid': '37058302', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of Rheumatoid Arthritis.\n2. Have a smartphone\n3. Must be able to access disease activity by themselves\n\nExclusion Criteria:\n\n1. Not able to access disease activity by themselves\n2. Lacks the ability of self-management\n3. Mental disorders or severe physical dysfunction\n4. Extremely poor compliance'}, 'identificationModule': {'nctId': 'NCT03715595', 'acronym': 'T2TRAonSSDM', 'briefTitle': 'The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Treat-to-target Study of Rheumatoid Arthritis Based on Smart System of Disease Management(SSDM) : A Randomized Controlled Multicenter Trial', 'orgStudyIdInfo': {'id': '2018PHB065-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSDM group', 'description': 'The patients in will use the SSDM at home every month for one year.', 'interventionNames': ['Other: SSDM group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', '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.'}], 'interventions': [{'name': 'SSDM group', 'type': 'OTHER', 'otherNames': ['control group'], '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.', 'armGroupLabels': ['SSDM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Li, Doctor', 'role': 'CONTACT', 'email': '13811190098@163.com', 'phone': '8610-13811190098'}, {'name': 'Zhanguo Li, Doctor', 'role': 'CONTACT', 'email': 'zgli99@aliyun.com', 'phone': '8610-13910713924'}], 'facility': 'Chun Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhanguo Li, Doctor', 'role': 'CONTACT', 'email': 'fiona_leechun@163.com', 'phone': '86-10-88324178'}], 'overallOfficials': [{'name': 'Chun Li, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Peking University International Hospital', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Dongguan donghua hospital', 'class': 'UNKNOWN'}, {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Hebei General Hospital', 'class': 'OTHER'}, {'name': 'Bethune International Peace Hospital', 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': "Subei People's Hospital of Jiangsu Province", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of BaoTou Medical College', 'class': 'OTHER'}, {'name': "Linyi People's Hospital", 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Mianyang Central Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': "The First People's Hospital of Yunnan", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Xijing Hospital', 'class': 'OTHER'}, {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}