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Validation of the Foot Health Status Questionnaire in French Language (FHSQ-Fr)

C

Centre Hospitalier Régional d'Orléans

Status

Enrolling

Conditions

Patients With Foot Problems

Treatments

Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT06933953
CHUO-2024-12

Details and patient eligibility

About

A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.

The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.

The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.

Full description

To assess validity, 150 volunteers will fill out French validated questionnaires, Foot Function Index (FFI), EuroQuality of life 5D-5L (EQ5D) , Visual Analogic Pain Scale (VAPS), and Short Form 12 Health survey (SF12). They will be evaluated about their pain, morphology, function and posture of their feet as usual at a podiatric school. To assess reliability, 50 respondents from the 150 who didn't receive any treatment after 7 to 10 days, will complete the FHSQ-fr again. It would improve knowledge of the status of foot health and its related quality of life in the general population and those suffering from specific pathologies such as diabetes or rheumatoid arthritis, the effectiveness of certain treatments on the same foot condition, and their evolutions using longitudinal studies in France. At the international, the French future results of studies using this clinimetric tool could be compared with those who come from other countries, and integrated to the Australian author's " Bigdataset" which compares, analyses and predicts more accurately the clinically significant efficacy of a treatment.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
  2. Age >= 18
  3. knowing how to speak, read and write French.

Exclusion criteria

  1. Have already taking part in this research before the proposition to get in.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Patients with foot problems
Other group
Description:
Patients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12
Treatment:
Other: Questionnaires

Trial contacts and locations

1

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Central trial contact

Stéphanie MARDHEL

Data sourced from clinicaltrials.gov

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