Knee OsteoarthritisASESNCT02977325
Validation of the Questionnaire ASES
An observational study of Knee Osteoarthritis and Physical Activity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Physical Activity, Education
- What is being tested?
- water cure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with knee osteoarthritis
Who may be able to join
- 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
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Physical Activity, Education, Self-management, Exercise
- Being tested
- water cure
- Keywords
- Physical activity level, Personal efficacy, Knee osteoarthritis, Self-management, Self-care, Education and exercise in knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water cureOther
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | One group participated in therapeutic programs centered on the physical activity Receives: Other: water cure | |
| water cure exclusively | This group followed exclusively the water cure Receives: Other: water cure |
What is being measured
The primary outcome is the main question the study is designed to answer.
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Measured: at 3 months
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Measured: at 3 months +15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Clermont Communauté, Innovatherm
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977325
- Sponsor's protocol ID
- CHU-0293
- Acronym
- ASES
- Status last verified
- Dec 2016
- First submitted
- 28 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cultural Adaptation of the Arthritis Self-Efficacy Scale
- ClinicalTrials.gov ID
- NCT02977325
- Acronym / sponsor ID
- ASES / CHU-0293
- Conditions
- Knee Osteoarthritis, Physical Activity, Education, Self-management, Exercise
- Keywords
- Physical activity level, Personal efficacy, Knee osteoarthritis, Self-management, Self-care, Education and exercise in knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Clermont Communauté, Innovatherm
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | – | Other: water cureOne group participated in therapeutic programs centered on the physical activity |
| water cure exclusively | – | Other: water cureThis group followed exclusively the water cure |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with knee osteoarthritis
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water cure | Other | Physical activity, water cure exclusively |
Primary outcome
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: at 3 months
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: at 3 months +15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Physical Activity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale" (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.