- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977325
Validation of the Questionnaire ASES (ASES)
Translation and Cultural Adaptation of the Arthritis Self-Efficacy Scale
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- CHU de Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Physical activity
One group participated in therapeutic programs centered on the physical activity
|
|
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water cure exclusively
This group followed exclusively the water cure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Time Frame: at 3 months
|
at 3 months
|
|
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Time Frame: at 3 months +15 days
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at 3 months +15 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0293
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