Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis (SandRA)

October 4, 2017 updated by: Medcare Oy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, FI-40620
        • Central Finland Central Hospital
      • Lappeenranta, Finland, FI-53130
        • South Karelia Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SandRA
cell phone monitoring
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.
No Intervention: Control
conventional monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
remission
Time Frame: at 6 months (co-primary 12 months)
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
Time Frame: at 0, 3, and 6 months
visual analogue scale
at 0, 3, and 6 months
quality of life
Time Frame: at 0, 3, and 6 months
SF-36
at 0, 3, and 6 months
drug adherence
Time Frame: during 6 months
stoppage of drugs, adverse events
during 6 months
consumption of resources
Time Frame: during 6 months
extra phone calls, extra visits
during 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medcare Oy

Investigators

  • Principal Investigator: Kari Puolakka, MD, PhD, South Carelia Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

January 30, 2016

Study Completion (Actual)

January 2, 2017

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SandRA-WI177026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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