Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients (GETT2)
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational workshops
Spa Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Physical Activity, Education, Dietary, Self-management
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
Sites / Locations
- Etablissement thermalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
7 educational workshops
spa therapy
Arm Description
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
Approved Spa therapy
Outcomes
Primary Outcome Measures
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
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
Functional status
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.
Pain intensity
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)
Life quality
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.
Comprehensive evaluation of patient education programs
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.
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
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.
Full Information
NCT ID
NCT03550547
First Posted
May 28, 2018
Last Updated
November 27, 2020
Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03550547
Brief Title
Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Acronym
GETT2
Official Title
Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
November 28, 2021 (Anticipated)
Study Completion Date
May 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Physical Activity, Education, Dietary, Self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
7 educational workshops
Arm Type
Experimental
Arm Description
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
Arm Title
spa therapy
Arm Type
Active Comparator
Arm Description
Approved Spa therapy
Intervention Type
Other
Intervention Name(s)
Educational workshops
Other Intervention Name(s)
Non pharmacological intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Spa Therapy
Other Intervention Name(s)
Non pharmacological intervention
Intervention Description
Approved Spa therapy of knee osteoarthritis patients
Primary Outcome Measure Information:
Title
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Description
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.
Time Frame
Month 06
Secondary Outcome Measure Information:
Title
Functional status
Description
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.
Time Frame
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Title
Pain intensity
Description
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)
Time Frame
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Title
Life quality
Description
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.
Time Frame
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Title
Comprehensive evaluation of patient education programs
Description
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.
Time Frame
Day 18, Month 03, Month 06, Month 09, Month 12
Title
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Description
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.
Time Frame
Day 01, Day 18, Month 03, Month 09, Month 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel COUDEYRE, MD-PhD
Phone
+33473750900
Email
ecoudeyre@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anna GOLDSTEIN
Phone
+33473750839
Email
agoldstein@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE, MD-PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etablissement thermal
City
Dax
State/Province
Aquitaine
ZIP/Postal Code
40100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Dubourg, Dr
Phone
05.58.56.89.94
Email
karine.dubourg@u-bordeaux.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
19734131
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.
Results Reference
background
PubMed Identifier
21123844
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.
Results Reference
background
PubMed Identifier
3068365
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.
Results Reference
background
PubMed Identifier
26343173
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.
Results Reference
background
PubMed Identifier
9180650
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.
Results Reference
background
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Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
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