Mobile Medically Supervised Patient Management in Rheumatoid Arthritis (MiDEAR)

September 25, 2023 updated by: Heinrich-Heine University, Duesseldorf

Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App

The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

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

  • Germany
      • Duesseldorf, Germany, 40225
        • Policlinic for Rheumatology & Hiller Research Centre for 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

RA patients

Description

Inclusion Criteria:

  • age >= 18 years, owner of App capable device, RA, informed consent

Exclusion Criteria:

  • non German speaking, no App capable device available

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RheumaLive App use
RheumaLive App use and evaluation of feasibility
Behavioral: RheumaLive App use
RheumaLive App use & threshold values
RheumaLive App use and evaluation of feasibility
Behavioral: RheumaLive App use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis.
Time Frame: baseline and change over up to nine months
Evaluation of use by counting and by a patient paper-based questionnaire
baseline and change over up to nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison paper-based vs electronic PROM in the App - Differences of the scores
Time Frame: baseline and change after 3 months
RADAI - Rheumatoid Arthritis Disease Activity Index and FFbH (Hannover Functional Ability Questionnaire ) / calculated HAQ (Health Assesment Questionnaire)
baseline and change after 3 months
Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis.
Time Frame: at 3 months from start and change over 6 more months
Evaluation of feasibility by a patient and a physician paper-based questionnaire
at 3 months from start and change over 6 more months
Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.
Time Frame: at 3 months from start and change over 6 more months
Evaluation of usability by a patient paper-based questionnaire
at 3 months from start and change over 6 more months

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Matthias Schneider, Prof., Heinrich-Heine University, Duesseldorf

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

November 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimated)

October 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiDEAR

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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