Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis
SandRA
1 other identifier
interventional
165
1 country
2
Brief Summary
The purpose of this study is to determine whether automated remote monitoring of patients with early rheumatoid arthritis by the SandRA software and short message service of cell phones increases patient compliance and helps to identify patients needing re-assessment of medication before scheduled visits. This might result in better clinical outcome and cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Aug 2013
Typical duration for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2017
CompletedOctober 5, 2017
October 1, 2017
2.5 years
April 20, 2015
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
remission
number of remissions at each arm, defined by no tender or swollen joints (44 joints) and normal CRP
at 6 months (co-primary 12 months)
Secondary Outcomes (4)
patient confidence
at 0, 3, and 6 months
quality of life
at 0, 3, and 6 months
drug adherence
during 6 months
consumption of resources
during 6 months
Study Arms (2)
SandRA
EXPERIMENTALcell phone monitoring
Control
NO INTERVENTIONconventional monitoring
Interventions
SandRA software sends SMS messages to a patient asking questions about the usage and adverse effects of prescribed drugs and about the severity of rheumatoid arthritis. The answer messages are interpreted automatically.
Eligibility Criteria
You may qualify if:
- Fulfillment of the EULAR 2010 classification criteria for rheumatoid arthritis
- Commencement of the first anti rheumatic medication
- Ability to use short message service of cell phones,
- Comprehension of the function of the SandRA monitoring system
- Willingness to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medcare Oylead
Study Sites (2)
Central Finland Central Hospital
Jyväskylä, FI-40620, Finland
South Karelia Central Hospital
Lappeenranta, FI-53130, Finland
Related Publications (7)
Mottonen T, Hannonen P, Leirisalo-Repo M, Nissila M, Kautiainen H, Korpela M, Laasonen L, Julkunen H, Luukkainen R, Vuori K, Paimela L, Blafield H, Hakala M, Ilva K, Yli-Kerttula U, Puolakka K, Jarvinen P, Hakola M, Piirainen H, Ahonen J, Palvimaki I, Forsberg S, Koota K, Friman C. Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. FIN-RACo trial group. Lancet. 1999 May 8;353(9164):1568-73. doi: 10.1016/s0140-6736(98)08513-4.
PMID: 10334255BACKGROUNDGrigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, Kincaid W, Porter D. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004 Jul 17-23;364(9430):263-9. doi: 10.1016/S0140-6736(04)16676-2.
PMID: 15262104BACKGROUNDBrus H, van de Laar M, Taal E, Rasker J, Wiegman O. Determinants of compliance with medication in patients with rheumatoid arthritis: the importance of self-efficacy expectations. Patient Educ Couns. 1999 Jan;36(1):57-64. doi: 10.1016/s0738-3991(98)00087-1.
PMID: 10036560BACKGROUNDSchoels M, Kapral T, Stamm T, Smolen JS, Aletaha D. Step-up combination versus switching of non-biological disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a retrospective observational study. Ann Rheum Dis. 2007 Aug;66(8):1059-65. doi: 10.1136/ard.2006.061820. Epub 2007 Feb 16.
PMID: 17307765BACKGROUNDRohekar G, Pope J. Test-retest reliability of patient global assessment and physician global assessment in rheumatoid arthritis. J Rheumatol. 2009 Oct;36(10):2178-82. doi: 10.3899/jrheum.090084. Epub 2009 Sep 15.
PMID: 19755617BACKGROUNDPincus T, Bergman M, Sokka T, Roth J, Swearingen C, Yazici Y. Visual analog scales in formats other than a 10 centimeter horizontal line to assess pain and other clinical data. J Rheumatol. 2008 Aug;35(8):1550-8. Epub 2008 Jun 15.
PMID: 18597409BACKGROUNDKuusalo L, Sokka-Isler T, Kautiainen H, Ekman P, Kauppi MJ, Pirila L, Rannio T, Uutela T, Yli-Kerttula T, Puolakka K; SandRA Study Group. Automated Text Message-Enhanced Monitoring Versus Routine Monitoring in Early Rheumatoid Arthritis: A Randomized Trial. Arthritis Care Res (Hoboken). 2020 Mar;72(3):319-325. doi: 10.1002/acr.23846.
PMID: 30740935DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kari Puolakka, MD, PhD
South Carelia Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2015
First Posted
April 23, 2015
Study Start
August 1, 2013
Primary Completion
January 30, 2016
Study Completion
January 2, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share