This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment sandra
Sponsor Medcare Oy
Start date August 2013
End date January 2016
Trial size 165 participants
Trial identifier NCT02424877, SandRA-WI177026


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
cell phone monitoring
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.
(No Intervention)
conventional monitoring

Primary Outcomes

time frame: at 6 months (co-primary 12 months)

Secondary Outcomes

patient confidence
time frame: at 0, 3, and 6 months
quality of life
time frame: at 0, 3, and 6 months
drug adherence
time frame: during 6 months
consumption of resources
time frame: during 6 months

Eligibility Criteria

Male or female participants at least 17 years old.

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.

Additional Information

Official title Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis
Principal investigator Kari Puolakka, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Medcare Oy.