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临床试验/NCT04378127
NCT04378127已完成不适用

Educational Therapy in Parkinson's Disease (PD): A Non-pharmacological Interventional, Multicentric, Randomized Controlled Trial.

IRCCS San Raffaele Roma0 个研究点目标入组 120 人开始时间: 2015年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
OFF hours

研究概览

简要总结

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. These can contribute to the burden of the disease on patients and their caregivers, and often remain unrecognized and untreated.

This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

详细描述

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. A multidisciplinary and comprehensive approach, based on the chronic care model, is considered the best way to manage motor and non-motor symptoms of the disease, although this model of care is still not standardized and previous trials showed conflicting results.

The study planned to enrol 40 advanced PD patients and related caregivers for each investigational site. This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • idiopathic Parkinson's disease (according to UK Brain Bank criteria)
  • being aged 20-80 years
  • being able to complete questionnaires
  • having no severe cognitive impairment (mini-mental state examination ≥24)
  • having a stable caregiver

排除标准

  • atypical parkinsonian
  • severe comorbidity significantly interfering with quality of life

结局指标

主要结局

OFF hours

时间窗: through study completion, an average of 1 year

The primary outcome was change from baseline to end of study in the mean daily OFF hours evaluated with the Hauser diary. Expected increase in the mean time spent in ON in at least 50% of treated patients (OR ≥1.5) compared to the control group.

次要结局

未报告次要终点

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

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