Knee OsteoarthritisGETT2NCT03550547
Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
A study testing Educational workshops and Spa Therapy in people with Knee Osteoarthritis, run by Association Francaise pour la Recherche Thermale at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Educational workshops and Spa Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2019to 28 May 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to the spa therapy
- Trouble behavior or understanding making it impossible to assess
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Etablissement thermal
Dax, Aquitaine, 40100
Karine Dubourg, Dr, 05.58.56.89.94, karine.dubourg@u-bordeaux.fr
About this study
Official title: Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Educational workshops, Spa Therapy
- Keywords
- Physical Activity, Education, Dietary, Self-management
- 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.
Educational workshopsOther
Also called Non pharmacological intervention
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
Spa TherapyOther
Also called Non pharmacological intervention
Approved Spa therapy of knee osteoarthritis patients
| Study group | Role | What they receive |
|---|---|---|
| 7 educational workshops | Experimental | 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 Receives: Other: Educational workshops; Other: Spa Therapy |
| spa therapy | Active comparator | Approved Spa therapy Receives: Other: Spa Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 06
Secondary outcomes (5)
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.
Measured: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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)
Measured: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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.
Measured: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
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.
Measured: Day 18, Month 03, Month 06, Month 09, Month 12
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.
Measured: Day 01, Day 18, Month 03, Month 09, Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start11 Mar 2019
- Primary completion28 Nov 2021 (estimated)
- Study completion28 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, MD-PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550547
- Sponsor's protocol ID
- 2017-A03323-50
- Acronym
- GETT2
- Status last verified
- Nov 2020
- First submitted
- 28 May 2018
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19734131Mendelson 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.
PubMed 21123844Bellamy 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.
PubMed 3068365Krasny-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.
PubMed 26343173Rockwood 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.
PubMed 9180650Goldstein A, Lanhers C, Gay C, Dubourg K, Grange L, Roques CF, Pereira B, Coudeyre E. Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial. Trials. 2023 Jan 19;24(1):45. doi: 10.1186/s13063-022-06879-5.
PubMed 36658607
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT03550547
- Acronym / sponsor ID
- GETT2 / 2017-A03323-50
- Conditions
- Knee Osteoarthritis
- Keywords
- Physical Activity, Education, Dietary, Self-management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 28 May 2022 (estimated)
- First posted
- 8 Jun 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 educational workshops | Experimental | Other: Educational workshops, Other: Spa TherapyIntervention: 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 |
| spa therapy | Active comparator | Other: Spa TherapyApproved Spa therapy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to the spa therapy
- Trouble behavior or understanding making it impossible to assess
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 |
|---|---|---|
| Educational workshopsAlso: Non pharmacological intervention1 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 | 7 educational workshops |
| Spa TherapyAlso: Non pharmacological interventionApproved Spa therapy of knee osteoarthritis patients | Other | 7 educational workshops, spa therapy |
Primary outcome
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.
5 secondary outcomes
Functional status
Time frame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Pain intensity
Time frame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Life quality
Time frame: Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Comprehensive evaluation of patient education programs
Time frame: Day 18, Month 03, Month 06, Month 09, Month 12
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Time frame: Day 01, Day 18, Month 03, Month 09, Month 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 19734131Forestier 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.
- Background: PubMed 21123844Mendelson 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.
- Background: PubMed 3068365Bellamy 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.
- Background: PubMed 26343173Krasny-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.
- Background: PubMed 9180650Rockwood 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.
- Derived from this study: PubMed 36658607Goldstein A, Lanhers C, Gay C, Dubourg K, Grange L, Roques CF, Pereira B, Coudeyre E. Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial. Trials. 2023 Jan 19;24(1):45. doi: 10.1186/s13063-022-06879-5.
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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, MD-PhD 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?
A study testing Educational workshops and Spa Therapy in people with Knee Osteoarthritis, run by Association Francaise pour la Recherche Thermale 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel COUDEYRE, MD-PhD (+33473750900, ecoudeyre@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring effectiveness of the educational workshops, personalized and determined for every patient. (time frame: Month 06). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550547, which also lists 6 linked publications.
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 30 Nov 2020.