Ignite Creation Date:
2025-12-18 @ 9:31 AM
Ignite Modification Date:
2025-12-18 @ 9:31 AM
Study NCT ID:
NCT04196647
Status:
None
Last Update Posted:
2022-11-02 00:00:00
First Post:
2019-06-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Guideline for Hometitration With Duodopa for Parkinson Patients
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
Status:
None
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: