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

NCT ID: NCT02317939

Last Updated: 2017-12-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A two-step multi-centre study with 240 rheumatoid arthritis patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

instruction

Intervention Type OTHER

online instruction tutorials at followup visits

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

Group Type ACTIVE_COMPARATOR

standard baseline instruction

Intervention Type OTHER

self-guidance at followup visits

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

instruction

online instruction tutorials at followup visits

Intervention Type OTHER

standard baseline instruction

self-guidance at followup visits

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Region Capital Denmark

OTHER

Sponsor Role collaborator

Henrik Gudbergsen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Henrik Gudbergsen

EU project coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hennning Bliddal, MD, DMSc

Role: STUDY_DIRECTOR

Parker RI

Henrik R Gudbergsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parker RI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Rheumatology

Frederiksberg, Capital Region, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.

Reference Type DERIVED
PMID: 31416921 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

100.01

Identifier Type: -

Identifier Source: org_study_id