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临床试验/NCT04783129
NCT04783129Unknown不适用

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

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Change in Health related Quality of life

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All groups will be assessed before (baseline), and after the end of the intervention by a blinded examiner

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Severe cognitive decline Severe visual impairment Severe hearing impairment

结局指标

主要结局

Change in Health related Quality of life

时间窗: 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

次要结局

  • Change in Montreal Cognitive Assessment scores(baseline and immediately after the end of intervention)
  • Change in Unifed Parkinson's Disease Rating Scale scores(baseline and immediately after the end of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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