Validation of the Foot Health Status Questionnaire in French Language

NCT06933953 | Recruiting

• 1 other identifier: CHUO-2024-12
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Foot Problems

Keywords

Surveys and Questionnaires; FHSQ French translation; Health status; Foot; Validity; Reliability

Outcome Measures

Primary Outcomes (3)

• Internal consistency

  It is evaluated using Cronbach's alpha coefficient "α", which measures the internal consistency of a set of items, scales or sub-scales for a single clinical dimension. The value of this index is less than or equal to 1, and the closer alpha is to 1, the stronger it is. α" \> 0.7 or \>0.8 is considered fairly high. However, the coefficient must not be too close to 1, otherwise the items are redundant and duplicate each other.

  Day 0

• Temporal stability of patients' questionnaire scores FHSQ-en V 1.02

  It is measured by the Intraclass Correlation Coefficient (ICC) and its 95% confidence interval, and/or the Pearson Correlation Coefficient. By convention, fidelity is said to be: * Very good if ICC ≥0 91 * Good if 0.9 ≤ ICC ≤ 0.71 * Moderate if 0.70 ≤ ICC ≤ 0.51 * Poor if 0.5 ≤ ICC ≤ 0.31 * Very poor or nil if ICC ≤ 0.3

  Day 0 and day 7

• Measurement error

  To apply the criterion of good measurement error, the MIC (Minimal Important Change), the SDC (Smallest Detectable Change) or the LoA (Limits of Agreement) load will be calculated using a longitudinal approach based on anchoring.

  Day 0

Study Arms (1)

Patients with foot problems

OTHER

Patients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12

Other: Questionnaires

Interventions

Questionnaires OTHER

Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12. Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time

Patients with foot problems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Ifres Ecole de Pedicure Podologie

Alençon, France

RECRUITING

Related Publications (4)

• Burzykowski T, Molenberghs G, Abeck D, Haneke E, Hay R, Katsambas A, Roseeuw D, van de Kerkhof P, van Aelst R, Marynissen G. High prevalence of foot diseases in Europe: results of the Achilles Project. Mycoses. 2003 Dec;46(11-12):496-505. doi: 10.1046/j.0933-7407.2003.00933.x.

  PMID: 14641624 BACKGROUND

• Lopez-Lopez D, Perez-Rios M, Ruano-Ravina A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Romero-Morales C, Calvo-Lobo C, Navarro-Flores E. Impact of quality of life related to foot problems: a case-control study. Sci Rep. 2021 Jul 15;11(1):14515. doi: 10.1038/s41598-021-93902-5.

  PMID: 34267276 BACKGROUND

• Valensi P, Girod I, Baron F, Moreau-Defarges T, Guillon P. Quality of life and clinical correlates in patients with diabetic foot ulcers. Diabetes Metab. 2005 Jun;31(3 Pt 1):263-71. doi: 10.1016/s1262-3636(07)70193-3.

  PMID: 16142017 BACKGROUND

• Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.

  PMID: 9770933 BACKGROUND

Related Links

• A few figures on foot health in France - UFSP

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Delphine GUYET

  IFRES of Alençon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie MARDHEL

CONTACT

0788586556; stephanie.mardhel@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: April 18, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)