Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— SandRA  

Official title:

Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424877
• Other study ID #: SandRA-WI177026
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: October 4, 2017
• Start date: August 1, 2013
• Est. completion date: January 2, 2017

Study information

• Verified date: October 2017
• Source: Medcare Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To improve monitoring of patients with early RA the investigators have developed an automated remote monitoring system SandRA (Showing-any-need-for-Re-Assessment) based on short message service (SMS) of cell phones and patients' global assessment of the severity of RA (PtGA) on a numeric scale of 0 to 10.

SandRA software sends every 2 to 6 weeks automatically an SMS to a patient's cell phone, and the patient answers by one push on keyboard. The patients' answers are recorded in SandRA and automatically analysed. If answers indicate non-adherence, adverse events, or missed target, the system automatically sends SMS: "Your nurse will call you within 2 work days", and the nurse gets an alarm by e-mail. If needed, an extra visit is arranged for treatment adjustment.

Preliminary studies show that PtGA given by cell phone has sufficient convergent validity. Structured feedback from patients has been favourable and most professionals assess the system as feasible.

The objective of this study is to investigate the impact of SandRA monitoring on clinical outcomes of RA, on patients' quality of life and drug adherence, as well as consumed resources. Cost-effectiveness of SandRa is estimated.

Methods Consecutive incident patients (200) with RA are enrolled. Those, who can use SMS messages of cell phone, who understand the SandRA system, and are willing, are included. After informed consent the patients are randomized into two groups: 1) SandRA group and 2) control group.

The patients randomized into SandRA group are instructed as usual. Regular doctor visits are scheduled at 3 months and at 6 months, when the SandRa monitoring ends. The following clinical data will be gathered. 1) ACR core data set at baseline, at 3 and 6 months, and at possible extra visits; 2) radiographs of the hands and the feet at baseline (if not taken within 6 months); 3) antirheumatic medication and the possible causes of switches and changes over the 6 months 4) patient confidence (VAS) at each doctor visit; 5) quality of life (SF-36) at baseline and at 6 months. Patient feedback of the system by a structured questionnaire is gathered at 6 months.

The patients in the control group are treated as usual. Follow-up visits are scheduled as needed. The same clinical data as in SandRA group are collected at baseline and at 6 months.

In the both groups concomitant diseases and medications as well as age, sex, and education level are recorded at baseline. The consumption of resources is assessed as the number of contacts (doctor visits, nurse visits, as well as phone calls scheduled and non-scheduled) with the outpatient clinic over the 6-month follow-up.

In addition, the patients are assessed at 12 months, when the ACR Core Data Set is gathered.

The radiographs at baseline and ACR Core Data Set at doctor visits, safety laboratory tests, and assessment visits at 3, 6, and 12 months are included in the normal clinical care. No extra visits are required because of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2, 2017
• Est. primary completion date: January 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Failure to fulfill the inclusion criteria.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• SandRA
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.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	South Karelia Central Hospital	Lappeenranta

Sponsors (1)

Lead Sponsor	Collaborator
Medcare Oy

Country where clinical trial is conducted

Finland, 

References & Publications (6)

Brus 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. — View Citation

Grigor 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. — View Citation

Möttönen T, Hannonen P, Leirisalo-Repo M, Nissilä M, Kautiainen H, Korpela M, Laasonen L, Julkunen H, Luukkainen R, Vuori K, Paimela L, Blåfield H, Hakala M, Ilva K, Yli-Kerttula U, Puolakka K, Järvinen P, Hakola M, Piirainen H, Ahonen J, Pälvimäki 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. — View Citation

Pincus 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. — View Citation

Rohekar 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. — View Citation

Schoels 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. Epub 2007 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient confidence	visual analogue scale	at 0, 3, and 6 months
Secondary	quality of life	SF-36	at 0, 3, and 6 months
Secondary	drug adherence	stoppage of drugs, adverse events	during 6 months
Secondary	consumption of resources	extra phone calls, extra visits	during 6 months