Validation of the French Version of the Health Assessment... | NCT03249467

Studies
Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis

NCT03249467

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Aug 25, 2017Actual

Enrollment

129Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2015Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 10, 2017

First Submission Date that Met QC Criteria

Aug 10, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2017

Last Update Posted Date

Aug 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to develop a validated French version of the HAQ-II questionnaire for rheumatoid arthritis.

Detailed Description

The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available in more than 60 languages and includes 42 items. However the questionnaire is not easy to use in the clinic : complicated questions, long to answer for the patient and not easy to score for the doctor.

The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as the HAQ and is simpler to administer and score. It includes 5 items already translated in English and 5 new items not yet translated.

The aim of the study is the validation of the French version of the HAQ-II for rheumatoid arthritis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Measure	Description	Time Frame
Internal validity, scale HAQ-II		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 18 years old
Patient with rheumatoid arthritis

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with rheumatoid arthritis

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided