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

2020년 11월 27일 업데이트: Association Francaise pour la Recherche Thermale

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.

연구 개요

상태

알려지지 않은

상세 설명

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.

연구 유형

중재적

등록 (예상)

250

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Aquitaine
      • Dax, Aquitaine, 프랑스, 40100

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
다른 이름들:
  • 비약물적 개입
Approved Spa therapy of knee osteoarthritis patients
다른 이름들:
  • 비약물적 개입
활성 비교기: spa therapy
Approved Spa therapy
Approved Spa therapy of knee osteoarthritis patients
다른 이름들:
  • 비약물적 개입

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
기간: 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.
Month 06

2차 결과 측정

결과 측정
측정값 설명
기간
Functional status
기간: 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.
Pain intensity
기간: 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)
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Life quality
기간: 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.
Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.
Comprehensive evaluation of patient education programs
기간: 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.

Day 18, Month 03, Month 06, Month 09, Month 12
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
기간: 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.
Day 01, Day 18, Month 03, Month 09, Month 12.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Emmanuel COUDEYRE, MD-PhD, University Hospital, Clermont-Ferrand

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 3월 11일

기본 완료 (예상)

2021년 11월 28일

연구 완료 (예상)

2022년 5월 28일

연구 등록 날짜

최초 제출

2018년 5월 28일

QC 기준을 충족하는 최초 제출

2018년 5월 28일

처음 게시됨 (실제)

2018년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 11월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 27일

마지막으로 확인됨

2020년 11월 1일

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Educational workshops에 대한 임상 시험

3
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