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Digitized Grip Strength

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Digitized sensor

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Rheumatoid arthritis whatever its activity
Above 18 years old patients

Exclusion Criteria:

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

Sites / Locations

UH Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RA patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02197507

First Posted

July 21, 2014

Last Updated

July 21, 2014

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02197507

Brief Title

Digitized Grip Strength

Official Title

Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RA patients

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Digitized sensor

Intervention Description

Measure of grip strength of the dominant hand

Primary Outcome Measure Information:

Title

grip strength

Description

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

Time Frame

visit 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Rheumatoid arthritis whatever its activity Above 18 years old patients Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Jorgensen, MD

Phone

04 67 33 72 31

c-jorgensen@chu-montpellier.fr

Facility Information:

Facility Name

UH Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Contact: