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

27 de novembro de 2020 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

250

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Aquitaine
      • Dax, Aquitaine, França, 40100

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

50 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

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
Outros nomes:
  • Intervenção não farmacológica
Approved Spa therapy of knee osteoarthritis patients
Outros nomes:
  • Intervenção não farmacológica
Comparador Ativo: spa therapy
Approved Spa therapy
Approved Spa therapy of knee osteoarthritis patients
Outros nomes:
  • Intervenção não farmacológica

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Measuring effectiveness of the educational workshops, personalized and determined for every patient.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functional status
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Emmanuel COUDEYRE, MD-PhD, University Hospital, Clermont-Ferrand

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de março de 2019

Conclusão Primária (Antecipado)

28 de novembro de 2021

Conclusão do estudo (Antecipado)

28 de maio de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

28 de maio de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2018

Primeira postagem (Real)

8 de junho de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de novembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2017-A03323-50

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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