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

NCT03715595 | Unknown DMC

• 1 other identifier: 2018PHB065-01
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

treat-to-target; smart system of disease management; drug use

Outcome Measures

Primary Outcomes (1)

• 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.

  six month

Secondary Outcomes (9)

• The rate of T2T between the two groups.

  twelve month

• The relapse rate between the two groups

  Six month and twelve month

• The safety of drug use between the two groups

  Six month and twelve month

• The compliance between the two groups

  Six month and twelve month

• The HADS between the two groups

  Six month and twelve month

Study Arms (2)

SSDM group

EXPERIMENTAL

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

Other: SSDM group

Control group

NO INTERVENTION

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

SSDM group 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.

Also known as: control group

SSDM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Rheumatoid Arthritis.
• Have a smartphone
• Must be able to access disease activity by themselves

You may not qualify if:

• Not able to access disease activity by themselves
• Lacks the ability of self-management
• Mental disorders or severe physical dysfunction
• Extremely poor compliance

Sponsors & Collaborators

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

Study Sites (1)

Chun Li

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (8)

• 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: 19036778 RESULT

• 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: 26290587 RESULT

• 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: 24872377 RESULT

• 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: 8948295 RESULT

• 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: 19382860 RESULT

• 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: 18615186 RESULT

• 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: 25903352 RESULT

• 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.

  PMID: 37058302 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Chun Li, doctor

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhanguo Li, Doctor

CONTACT

86-10-88324178; fiona_leechun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: May 29, 2020
• Study Completion: June 29, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)