이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Multidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease (AMPARO)

2021년 3월 3일 업데이트: University of Sao Paulo General Hospital

Multidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease: Comparison Between Remote and Face-to-face Delivery

The objective of this study is to compare the effects of two similar long-term interprofessional programs, one of them delivers by in-person classes, and another delivers by online classes on the quality of life of people with Parkinson's.

Method: People with PD will be randomized into 3 groups: (1) Face-to-face group, in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures; (2) Remote group, in which individuals followed the same lectures delivered by online; and (3) Control group, in which participants followed no lecture. The participants will be evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health quality of life was adopted as a primary outcome. Independence in daily living activities, motor and non-motor symptoms severity, and global cognitive capacity was adopted as secondary measures, Besides, all participants will be asked to answer a survey to evaluate the knowledge improvement of key learning points of lectures. The results will be analyzed by ANOVA for repeated measures.

연구 개요

상세 설명

Parkinson's disease is a large cause of disability worldwide. The complex combination of motor and non-motor symptoms brings an increasing impairment in functionality and, consequently, a progressively decrease in the quality of life of the people living with PD and their families. The World Health Organization (WHO) recommends that for health care, especially in chronic diseases, care should be centered on the person (people-centered care). This model enlarges the focus on biological aspects, including psychological and social aspects, building a multidimensional perspective on an individual, which can only be reached by integrated and interprofessional care.

According to this model, education is crucial to empower the person to occupy an active role in the health process, gaining greater control over decisions and actions affecting their health. Patient empowerment has been associated with positive health and clinical outcomes, including improved disease management, effective use of health services, improved health status, and medication adherence. However, there are several barriers for participants to attending this kind of program. Reasons for nonparticipation include mobility-reducing physical health issues, time constraints, distance, insufficient funds, lack of respite care if caring for someone else, and transportation. Thus, using a home-based video class may be one opportunity to reduce these known barriers and improve the accessibility of education programs. This delivery strategy can be beneficial for no high-income countries.

Objective: The objective of this study is to compare the effects of two similar long-term interprofessional programs, one of them delivers by in-person classes, and another delivers by online classes on the quality of life of people with Parkinson's.

Method: People with a confirmed diagnosis of Idiopathic Parkinson's disease, in stage 1-4 of disease evolution according to Hoehn and Yahr classification will be randomized into 3 groups: (1) Face-to-face group (FFG), in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures; (2) Remote group (RG), in which individuals followed the same lectures delivered by online; and (3) Control group (CG), in which participants followed no lecture. People who have severe cognitive decline and uncorrected visual or hearing impairment will be excluded. Participants from both groups will be instructed to follow their usual routine for the treatment of the disease. The lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist. The participants will be evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health quality of life, adopted as a primary outcome, will be evaluated by Parkinson´s disease questionnaire 39 (PDQ-39). The independence in daily living activities, motor and non-motor symptoms severity, and global cognitive capacity, adopted as secondary measures, will be evaluated by Unified Parkinson´s disease rating scale (UPDRS) and Montreal Cognitive Assessment (MoCA), respectively. Besides, all participants will be asked to answer a survey to evaluate the knowledge improvement of key learning points of lectures. The survey consisted of 20 questions (2 per lecture) where the minimum level (score 0) indicated the absence of knowledge and maximal level (score 5) indicated the full understanding of lectures' key points. The results will be analyzed by ANOVA for repeated measures considering as factor group (FFG, RG, CG) and assessment points (BED, AEP).

연구 유형

중재적

등록 (실제)

45

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • SP
      • Sao Paulo, SP, 브라질, 05360-160
        • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

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

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Clinical diagnosis of Idiopathic Parkinson's disease Must have acess to internet.

Exclusion Criteria:

Severe cognitive decline Severe visual impairment Severe hearing impairment

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Face-to-face group
Face-to-face group (FFG), in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures
The education program consist of 10 lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist.
활성 비교기: Remote group
Remote group (RG), in which individuals followed 10 monthly remote lectures
The education program consist of 10 lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist.
가짜 비교기: Control group
Control group (CG), in which participants followed no education program (lectures)
Participants will follow no education program (lecture) and will be instructed to follow their usual routine for the treatment of the disease

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Health related Quality of life
기간: baseline and immediately after the end of intervention
Parkinson´s disease questionnaire 39 (PDQ-39), PDQ-39 is a widely used and acknowledged disease-specific, self-reported questionnaire. It contains 39 questions covering eight distinct domains: mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort. The score for each question ranges from 0 to 4 points, with higher scores indicating higher levels of perceived problems. A change of ≥1.6 points on the PDQ-39 total score after 6 months represents a minimally clinically important difference
baseline and immediately after the end of intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Unifed Parkinson's Disease Rating Scale scores
기간: baseline and immediately after the end of intervention
UPDRS - Part I: Non-Motor Experiences of Daily Living which has six rater-based items and seven for patient self-assessment; UPDRS - Part II: Motor experiences of daily living, with 13 patient-based items; UPDRS - Part III: Motor examination, 18 items based on clinical tests. Each item scores from 0 (normal) to 4 (severe) and total scores are obtained from the sum of the corresponding item scores for each part.
baseline and immediately after the end of intervention
Change in Montreal Cognitive Assessment scores
기간: baseline and immediately after the end of intervention
Montreal Cognitive Assessment (MoCA): The 30-point designed to detect mild cognitive impairment and reportedly takes <10 min to administer with scores <26 defined as abnormal.
baseline and immediately after the end of intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 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)

2020년 3월 1일

기본 완료 (예상)

2021년 4월 30일

연구 완료 (예상)

2022년 4월 1일

연구 등록 날짜

최초 제출

2021년 2월 25일

QC 기준을 충족하는 최초 제출

2021년 3월 3일

처음 게시됨 (실제)

2021년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 3월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 3월 3일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

파킨슨병에 대한 임상 시험

구독하다