Clinical trial NCT03550547: Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Official title: Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Physical Activity
Education
Dietary
Self-management
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2018-06-08
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this work is to measure the efficiency of 18 days SPA Therapy in orientation rheumatology associated with an educational intervention in patients with knee osteoarthritis on a priority objective, personalized and determined by the patient, chosen in the list of 5 objectives determined during the educational assessment.

Detailed description: This program begin with a shared educational balance assessment allowing to set up the individual program adapted to the objectives personalized by the patients. The objectives to achieve are to allow the patients to acquire knowledge and skills (attitudes, behavior) concerning their pathology and the existing treatment. A multidisciplinary team trained in the therapeutic education of the patient assure the educational interventions. The proposed educational activities (7 educational workshops) concern major axes of the care of the knee osteoarthritis: knowledge of the pathology, the adapted physical exercise, the dietetics, the management of the pain, the articular hygiene and the technical helps.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring effectiveness of the educational workshops, personalized and determined for every patient.
timeFrame: Month 06
Secondary outcomes:
measure: Functional status
timeFrame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
measure: Pain intensity
timeFrame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
measure: Life quality
timeFrame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
measure: Comprehensive evaluation of patient education programs
timeFrame: Day 18, Month 03, Month 06, Month 09, Month 12
measure: Measuring effectiveness of the educational workshops, personalized and determined for every patient.
timeFrame: Day 01, Day 18, Month 03, Month 09, Month 12.
Other outcomes:
Locations:
city: Dax
country: France
facility: Etablissement thermal
state: Aquitaine
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel COUDEYRE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.