Rheum@Home: RA Remote Patient Monitoring

NCT ID: NCT05725577

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-06-01

Brief Summary

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The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.

Participants will be asked to

* complete questionaires every 4 weeks
* perform a walking test every 4 weeks
* routine lab
* routine disease activity measurement by a qualified assessor

Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Care via the telemedicine system

Intervention

Group Type OTHER

care via the telemedicine system

Intervention Type OTHER

Care via the telemedicine system

Standard care

Control

Group Type OTHER

Routine care

Intervention Type OTHER

Routine care

Interventions

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care via the telemedicine system

Care via the telemedicine system

Intervention Type OTHER

Routine care

Routine care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all consecutive patients;
* signed, written informed consent;
* 18 -75 years of age;
* clinical diagnosis of RA;
* ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
* able to read and understand simple Dutch language instructions;
* ownership or access to a smartphone, tablet or computer and having internet access;
* able to conduct a teleconsultation on a smartphone, tablet or computer.

Exclusion Criteria

* severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Twente

OTHER

Sponsor Role collaborator

Reade Rheumatology Research Institute

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role lead

Responsible Party

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Harald E. Vonkeman

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harald Vonkeman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Twente

Locations

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Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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R@H

Identifier Type: -

Identifier Source: org_study_id

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