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临床试验/NCT05251298
NCT05251298招募中不适用

"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"- Evaluates the Efficacy of an Online Platform That Allows Neurologists and Therapists to Exchange Therapy Recommendations Regarding Their Patients With Parkinson's Disease (PwP), Communicate Assessments and Plan Physical Therapy, Occupational Therapy as Well as Speech and Swallowing Therapy

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2021年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
370
试验地点
1
主要终点
Change in Quality of Life measured by PDQ 39

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of an online platform that allows neurologists and therapists to exchange therapy recommendations, communicate assessments and plan physical therapy, occupational therapy as well as speech and swallowing therapy for their patients.

详细描述

The aim of this study is to enroll 185 patients in the intervention group and 185 patients in the control group. Patients in the intervention group come from the same region (Münsterland), the control group will consist of patients outside this region. The patients in the intervention group undergo therapies planned and coordinated through the online platform for 12 months. The patients in the intervention group will be evaluated using the PDQ-39, UPDRS, H&Y as well as Schwab & England. The patients in the control group will be evaluated using the PDQ-39.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •(Intervention Group):
  • •Idiopathic Parkinson's Disease with pharmacological treatment
  • •30 years old or older
  • •place of residence: Münsterland, Tecklenburger Land, Kreis and Stadt Osnabrück
  • •sufficient knowledge of the German language, should be able to understand the consent form

排除标准

  • •severe cognitive deficits
  • •Atypical Parkinsonian Disorders
  • •participation in other studies

研究组 & 干预措施

Intervention group

Active Comparator

Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.

干预措施: Coordination through the online platform "JamesAKTIV" (Other)

Control group

No Intervention

Patients in the control group will undergo their usual therapies as prescribed by their neurologists.

结局指标

主要结局

Change in Quality of Life measured by PDQ 39

时间窗: Change from Baseline PDQ 39 at 12 months

The Parkinson's Disease Questionnaire (PDQ-39, max. score of 100 indicates the worst quality of life)

次要结局

  • Change in disease severity measured by Hoehn & Yahr(Change from Baseline UPDRS at 12 months)
  • Change in mobility, measured by Schwab- & England-Scale(Change from Baseline Schwab-&England-Scale at 12 months)
  • Change in disease severity measured by UPDRS(Change from Baseline UPDRS at 12 months)
  • Change in Health-related resource use in the elderly population, assessed by FIMA(Change from Baseline FIMA at 12 months)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tobias Warnecke

Professor Dr. Tobias Warnecke

University Hospital Muenster

研究点 (1)

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