Validation of the Questionnaire ASES

Completed

• Conditions: Knee Osteoarthritis; Exercise; Physical Activity; Self-management; Education
• Interventions: Other: water cure

• Registration Number: NCT02977325
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Questionnaires are often irreplaceable tools of collection of information in research and in the clinical practice. Coupled with other measures, they can be simple complementary tools, but questionnaires are sometimes the only way to collect data, such as self-service efficacy.

The objective of this study is a validation of the French translation of the ASES. To guarantee the comparability between the original version and the translated version, the translation of a questionnaire supposes two essential stages: a literal translation and an adaptation to the cultural context, to the habits of life and to the idioms of the target population. This new version will afterward be validated with patient's troop.

Detailed Description

The investigators are particularly interested in the Arthritis Self-Efficacy Scale (ASES), conceived to highlight a change of the faith of the patients in their capacities to make usual thinks or behaviour in front of consequences of the degenerative osteoarthritis, further to a therapeutic education.

The ASES is an auto-questionnaire compound of 20 items, from 0 to 10 on a digital scale and distributed in three domains: control of the pain (on 50), function (on 90) and other symptoms (on 60).

This questionnaire was already translated into Swedish, Dutch and Turkish.

Translation of the ASES and cultural adaptation :

The translation of the ASES in French followed the recommendations of the literature, which recommend a double translation, then a double back - translation with synthesis of the data in every stage. A final commission deliberate then a final translation, culturally adapted.

Patients' cohort and procedure of validation :

The prospective validation will be made with patients affected by degenerative osteoarthritis who fill the questionnaire ASES. These patients arose from cures of three thermal establishments of Auvergne. One group participated in therapeutic programs centered on the physical activity; the other one followed exclusively the water cure and received at the end of the cure an explanatory notebook on the degenerative osteoarthritis with physical exercises centered on the muscular strengthening of lower limbs.

Feedback :

Assessments conducted by the using of self - questionnaires:

- Sent by mail to the patients and back at 3 and 3,5 months

Ethics:

A written consent was collected before inclusion in the study and a document intended for the information was given to the patient. The study is anonymous, indeed, index forms will be coded before IT processing to guarantee the anonymity of the patient.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-08
• Study Completion: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
water cure exclusively	water cure	This group followed exclusively the water cure
Physical activity	water cure	One group participated in therapeutic programs centered on the physical activity

Primary Outcome Measures

Name	Time	Method
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"	at 3 months +15 days

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France