Validation of the Questionnaire ASES

Knee Osteoarthritis Clinical Trial

— ASES  

Official title:

Translation and Cultural Adaptation of the Arthritis Self-Efficacy Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977325
• Other study ID #: CHU-0293
• Status: Completed
• Phase: N/A
• First received: November 28, 2016
• Last updated: December 2, 2016
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

Inclusion criteria :

Both sexes, 50-75 years old Knee osteoarthritis Patients affiliated to a social security scheme Patients realizing a Spa Therapy Acceptance to participate in the study

Exclusion criteria :

< 50-year-old patients or > 75 years Inflammatory, tumoral, traumatic or infectious rheumatism Cardiac decompensation Disorders of the concentration or the compression of the written or oral French language.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Education
• Exercise
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Physical Activity
• Self-management

Intervention

Other:
• water cure

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Clermont Communauté, Innovatherm

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"		at 3 months	Yes
Primary	personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"		at 3 months +15 days	Yes