Rheumatoid Arthritis Clinical Trial
Official title:
Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis
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.
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.
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