Validation of the Foot Health Status Questionnaire in French Language
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Questionnaires.
- Кому может быть актуально
- Состояния в реестре: Patients With Foot Problems. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Psychometric Validation of the Foot Health Status Questionnaire in French Language
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Questionnaires
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
Первичные конечные точки
- Internal consistency [Срок оценки: Day 0]
- Temporal stability of patients' questionnaire scores FHSQ-en V 1.02 [Срок оценки: Day 0 and day 7]
- Measurement error [Срок оценки: Day 0]
Критерии участия
Критерии включения
- Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
- Age >= 18
- knowing how to speak, read and write French.
Критерии исключения
1\. Have already taking part in this research before the proposition to get in.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- Ifres Ecole de Pedicure Podologie — Alençon
Публикации
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT06933953 · CHUO-2024-12