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Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients (GETT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550547
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Educational workshops Other: Spa Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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

Other: Educational workshops
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
Other Name: Non pharmacological intervention

Other: Spa Therapy
Approved Spa therapy of knee osteoarthritis patients
Other Name: Non pharmacological intervention

Active Comparator: spa therapy
Approved Spa therapy
Other: Spa Therapy
Approved Spa therapy of knee osteoarthritis patients
Other Name: Non pharmacological intervention




Primary Outcome Measures :
  1. Measuring effectiveness of the educational workshops, personalized and determined for every patient. [ Time Frame: 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:

    • If the patient achieves the expected level, this is scored at 0.
    • If they achieve a better than expected outcome this is scored at: +1 (more than expected), +2 (much more than expected)
    • If they achieve a worse than expected outcome this is scored at: -1 (less than expected) or -2 (much less than expected) GAS depends on two things - the patient's ability to achieve their goals and the clinician's ability to predict outcome, which requires knowledge and experience.


Secondary Outcome Measures :
  1. Functional status [ Time Frame: 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.


  2. Pain intensity [ Time Frame: 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)

  3. Life quality [ Time Frame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12. ]
    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.

  4. Comprehensive evaluation of patient education programs [ Time Frame: Day 18, Month 03, Month 06, Month 09, Month 12 ]

    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.


  5. Measuring effectiveness of the educational workshops, personalized and determined for every patient. [ Time Frame: 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:

    • If the patient achieves the expected level, this is scored at 0.
    • If they achieve a better than expected outcome this is scored at: +1 (more than expected), +2 (much more than expected)
    • If they achieve a worse than expected outcome this is scored at: -1 (less than expected) or -2 (much less than expected) GAS depends on two things - the patient's ability to achieve their goals and the clinician's ability to predict outcome, which requires knowledge and experience.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550547


Contacts
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Contact: Emmanuel COUDEYRE, MD-PhD +33473750900 ecoudeyre@chu-clermontferrand.fr
Contact: Anna GOLDSTEIN +33473750839 agoldstein@chu-clermontferrand.fr

Locations
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France
Etablissement thermal Recruiting
Dax, Aquitaine, France, 40100
Contact: Karine Dubourg, Dr    05.58.56.89.94    karine.dubourg@u-bordeaux.fr   
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Emmanuel COUDEYRE, MD-PhD University Hospital, Clermont-Ferrand
Publications:
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Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT03550547    
Other Study ID Numbers: 2017-A03323-50
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Francaise pour la Recherche Thermale:
Physical Activity
Education
Dietary
Self-management
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases