NCT02197507

Brief Summary

Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults. Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also validated questionnaires for self-assessment of the disease by the patient. Grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with RA. Main Objective : To evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28 Secondary objective : Evaluate the correlation between grip strength of the dominant hand and :

  • scores of fatigue and pain (VAS and FACIT)
  • the self-assessment scores known in RA : functional index Health Assessment Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5. It is a cross-sectional study involving 150 patients followed in our department for RA. Grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

July 21, 2014

Last Update Submit

July 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • grip strength

    Evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28

    visit 1

Study Arms (1)

RA patients

EXPERIMENTAL
Device: Digitized sensor

Interventions

Measure of grip strength of the dominant hand

RA patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis whatever its activity
  • Above 18 years old patients

You may not qualify if:

  • Other condition that may affect the level of fatigue and / or grip strength
  • Insufficient level of understanding to perform the measurement and self-report questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Christian Jorgensen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 22, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations