Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: SandRA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SandRA<br>cell phone monitoring | Procedure: SandRA<br>* 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.<br>|
| No Intervention: Control<br>conventional monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient confidence | visual analogue scale | at 0, 3, and 6 months | 
| quality of life | SF-36 | at 0, 3, and 6 months | 
| drug adherence | stoppage of drugs, adverse events | during 6 months | 
| consumption of resources | extra phone calls, extra visits | during 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, drug treatment, compliance, outcome