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Validation of the Questionnaire ASES

NCT ID: NCT02977325

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis Physical Activity Education Self-management Exercise

Keywords

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Physical activity level Personal efficacy Knee osteoarthritis Self-management Self-care Education and exercise in knee osteoarthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Physical activity

One group participated in therapeutic programs centered on the physical activity

water cure

Intervention Type OTHER

water cure exclusively

This group followed exclusively the water cure

water cure

Intervention Type OTHER

Interventions

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water cure

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clermont Communauté

OTHER

Sponsor Role collaborator

Innovatherm

INDUSTRY

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel COUDEYRE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU-0293

Identifier Type: -

Identifier Source: org_study_id