- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196647
Guideline for Hometitration With Duodopa for Parkinson Patients
Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
The purpose of this study is to
- Create a guide for hometitration of Duodopa for patients with Parkinson's disease
- Outline which patients could be considered for "hometitration"
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Glostrup
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Copenhagen, Glostrup, Denmark, 2600
- Neurologisk Klinik, Rigshospitalet Glostrup
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Idiopathic Parkinson Disease (UK Parkinson's Disease Society Brain Bank criteria-UK PDSBB)
- Patient must be self-sufficient, or have access to support in own home (spouse, nursing home, home-nurse)
- Motivated and comfortable with home treatment and telemedicine (tablet provided by the clinic)
Exclusion Criteria:
- Patients not eligible for Duodopa-treatment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 14 days after titration
|
Satisfaction questionnaire specific for study.
10 questions with a scale from highly satisfied to not at all satisfied.
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14 days after titration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hoehn Yahr staging of Parkinson's disease
Time Frame: 2 month
|
Scale to acces severity of symptoms of Parkinsons disease.
|
2 month
|
Montreal Cognitive Assesment (MOCA)
Time Frame: 2 month
|
Version 7.0, www.mocatest.org.
Maximum points 30 (no sign of cognitive malfunction.
|
2 month
|
Parkinsons Disease Questionnaire 39 (PD-Q39)
Time Frame: 2 month
|
39 questions for the patients to rate QoL in Parkinson's Disease.
|
2 month
|
Unified Parkinsons Disease Rating Scale III (UPDRS)
Time Frame: 2 month
|
Scale on assesment of severity of disease induced symptoms.
A total of 199 points represents the worst (total) disability.
|
2 month
|
Barthel-20 index
Time Frame: 2 month
|
Version 30/11-2017, Maximum score 20.
|
2 month
|
Non-Motor Symptom Scale (NMSS)
Time Frame: 2 month
|
Scale to identify non-motor symptoms within 9 domains, score fra 0 to 3, where 0 are no symptoms in that area and 3 is severe.
|
2 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bo Biering-Sørensen, Director, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15010036
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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