Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study (ELECTOR_I)

December 20, 2017 updated by: Henrik Gudbergsen
A two-step multi-centre study with 240 rheumatoid arthritis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A two-step multi-centre study containing:

A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data

AND

An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors

Study Type

Interventional

Enrollment (Actual)

240

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

  • Denmark
    • Capital Region
      • Frederiksberg, Capital Region, Denmark, 2000
        • Department of Rheumatology

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with RA ≥ 12 months
  • DAS28-CRP < 5,1

Exclusion Criteria:

  • Dementia or other linguistic/cognitive/physical deficiency that prevents participation
  • Vision impairment that prevents the use of the devices and computer

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: online instruction at followup visits
patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
Other: instruction
online instruction tutorials at followup visits
Active Comparator: standard baseline instruction
after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home
Other: standard baseline instruction
self-guidance at followup visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intrarater reliability of DAS28 done by patients
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Interrater agreement of DAS28CRP
Time Frame: Baseline
Baseline
Intrarater reliability of joints counts performed by patients
Time Frame: Baseline
Baseline
Intrarater reliability of joint scores performed by patients
Time Frame: 8 weeks
8 weeks
Inter- and intrarater realiabilty of DAS38
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Henrik Gudbergsen

Collaborators

Charles University, Czech Republic
Region Capital Denmark

Investigators

  • Study Director: Hennning Bliddal, MD, DMSc, Parker RI
  • Principal Investigator: Henrik R Gudbergsen, MD, PhD, Parker RI

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

December 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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