- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03550547
Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients (GETT2)
Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Aquitaine
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Dax, Aquitaine, Frankrike, 40100
- Rekruttering
- Etablissement thermal
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Ta kontakt med:
- Karine Dubourg, Dr
- Telefonnummer: 05.58.56.89.94
- E-post: karine.dubourg@u-bordeaux.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients, male or female, aged 50 to 75 years
- Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)
- Patient affiliated to a social security scheme (beneficiary entitled)
- Patient registered spa
- Pain intensity equal or more than "3" at the Visual Analogical Scale
- Patient has given its consent in writing to
Exclusion Criteria:
- Contraindication to the spa therapy
- Trouble behavior or understanding making it impossible to assess
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 7 educational workshops
Intervention: 7 educational workshops in addition to spa therapy : Knowledge of the pathology ; Educational physical activity ( 2 workshops); Dietary; Management of pain, fatigue and the medical treatments; Articular hygiene and ergonomics; Technical assistance, an adaptation of the living condition |
1 workshop : Knowledge of the pathology ; 2a workshop: Educational physical activity; 2b workshop : Educational physical activity; 4 workshop : Dietary; 5 workshop : Management of pain, fatigue and the medical treatments; 6 workshop : Articular hygiene and ergonomics; 7 workshop : Technical assistance, an adaptation of the living condition
Andre navn:
Approved Spa therapy of knee osteoarthritis patients
Andre navn:
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Aktiv komparator: spa therapy
Approved Spa therapy
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Approved Spa therapy of knee osteoarthritis patients
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Tidsramme: Month 06
|
Average change from effectiveness of the educational workshops, personalized and determined for every patient, measured by a GAS GAS (Goal Attainment Scaling in Rehabilitation) is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure but this is scored in a standardized way as to allow statistical analysis. Each goal is rated on a 5-point scale, with the degree of attainment captured for each goal area:
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Month 06
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Functional status
Tidsramme: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
|
Score on WOMAC The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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Pain intensity
Tidsramme: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
|
Average change from baseline in the pain intensity measured on a Visual Analogical Scale (VAS) Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
A higher score indicates greater pain intensity.
The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
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Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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Life quality
Tidsramme: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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Average change from baseline of the Life quality, measured by a SF36.
It is one of the most widely used generic measures of health-related quality of life and has been shown to discriminate between subjects with different chronic conditions and between subjects with different severity levels of the same disease.
The SF-36 has also demonstrated sensitivity to significant treatment effects in a variety of patient populations.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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Comprehensive evaluation of patient education programs
Tidsramme: Day 18, Month 03, Month 06, Month 09, Month 12
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Average change from baseline of the comprehensive evaluation of patient education programs , measured by a HEIQ. The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. |
Day 18, Month 03, Month 06, Month 09, Month 12
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Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Tidsramme: Day 01, Day 18, Month 03, Month 09, Month 12.
|
Average change from effectiveness of the educational workshops, personalized and determined for every patient, measured by a GAS GAS (Goal Attainment Scaling in Rehabilitation) is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure but this is scored in a standardized way as to allow statistical analysis. Each goal is rated on a 5-point scale, with the degree of attainment captured for each goal area:
|
Day 01, Day 18, Month 03, Month 09, Month 12.
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Emmanuel COUDEYRE, MD-PhD, University Hospital, Clermont-Ferrand
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Rockwood K, Joyce B, Stolee P. Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients. J Clin Epidemiol. 1997 May;50(5):581-8. doi: 10.1016/s0895-4356(97)00014-0.
- Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
- Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
- Mendelson AD, McCullough C, Chan A. Integrating self-management and exercise for people living with arthritis. Health Educ Res. 2011 Feb;26(1):167-77. doi: 10.1093/her/cyq077. Epub 2010 Dec 1.
- Krasny-Pacini A, Evans J, Sohlberg MM, Chevignard M. Proposed Criteria for Appraising Goal Attainment Scales Used as Outcome Measures in Rehabilitation Research. Arch Phys Med Rehabil. 2016 Jan;97(1):157-70. doi: 10.1016/j.apmr.2015.08.424. Epub 2015 Sep 4.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2017-A03323-50
Legemiddel- og utstyrsinformasjon, studiedokumenter
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