Education in Therapy of Parkinson's Disease (ETPARK)
EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE
Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD.
The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up.
The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs.
This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations.
The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Toulouse, 프랑스, 31000
- Uh Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- Parkinson's disease patients with a score ≤4 on the Hoehn and Year scale
- Patient without cognitive disorders
- Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine agonists,ICOMT…) or DBS stimulation (since at least 3 month)
- Patients able to fulfil self-administered questionnaire
- Patients affiliated to a social protection program
Exclusion Criteria:
- - Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…)
- Parkinson's disease patients with a score>5 on the Hoehn and Yahr scale
- Patients suffering of parkinsonism induce by drugs
- Patients with important tremors during a OFF conditions
- Patients ever included in another study
- Patients with severe psychiatric disease
- Patients under tutelage, curatelle or law protection
- Patients included in an other clinical study
- Patients unable to fulfil scales of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: traditional medical care
patients benefiting of a traditional medical care
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실험적: therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
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The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Quality of life with the PDQ39 scale
기간: 1 year
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1 year
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Quality of life with the SF36 scale
기간: 1 year
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1 year
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the motor state with UPDRS (Unified Pakinson's disease Rating Scale)
기간: 1 year
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1 year
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The psychological state with HAD (Hospital Anxiety and Depression) scale
기간: 1 year
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1 year
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Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale
기간: 1 year
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1 year
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Evaluation of medical costs
기간: over the 12 months follow-up
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over the 12 months follow-up
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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