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临床试验/NCT04196647
NCT04196647已完成不适用

Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

The purpose of this study is to

  1. Create a guide for hometitration of Duodopa for patients with Parkinson's disease
  2. Outline which patients could be considered for "hometitration"

详细描述

To start treatment with continuous intestinal levodopa infusion to the duodenum (Duodopa-pump) in patients with Idiopathic Parkinson Disease (IPD), it is usually required that the patient is hospitalised to test if Duodopa works for the patient and for the titration process to find the relevant dosage before operation and connection of the pump.

A hospitalisation is very costly. Experience shows, that this group of patients are often very stressed during hospitalisation because of noise, impaired sleep and unfamiliar surroundings. These conditions make fast and effective dosage titration very difficult, and experience also shows that the dosage often needs to be recalibrated once the patient is back home in familiar surroundings.

The use of TeleMedicin (TM) is on the rise in Denmark as well as other international health care systems.

These factors were the basis for the home-titration study where patients have their initial dosage titration done in their own home, supported by one visit from nursing staff, and one TM (video consultation) a day. The goal is to make the titration process more effective, reduce cost by treating the patient in their own home and making the patient more satisfied with the titration process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients not eligible for Duodopa-treatment

结局指标

主要结局

Patient satisfaction

时间窗: 14 days after titration

Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied.

次要结局

  • Unified Parkinsons Disease Rating Scale III (UPDRS)(2 month)
  • Hoehn Yahr staging of Parkinson's disease(2 month)
  • Montreal Cognitive Assesment (MOCA)(2 month)
  • Parkinsons Disease Questionnaire 39 (PD-Q39)(2 month)
  • Barthel-20 index(2 month)
  • Non-Motor Symptom Scale (NMSS)(2 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Biering-Soerensen

Attending

Rigshospitalet, Denmark

研究点 (1)

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