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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The purpose of this study is to
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home titration | Other | Patients have their initial dosage titration of duodopa done in their own home, supported by one visit from nursing staff, and one video consultation a day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied. | 14 days after titration |
| Measure | Description | Time Frame |
|---|---|---|
| Hoehn Yahr staging of Parkinson's disease | Scale to acces severity of symptoms of Parkinsons disease.
|
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Inclusion criteria:
Exclusion Criteria:
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Patients with advanced parkinson, reffered to Duodopa treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Bo Biering-Sørensen, Director | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologisk klinik, Rigshospitalet Glostrup | Copenhagen | Glostrup | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38623494 | Derived | Thomsen TH, Nielsen NS, Isenberg AL, Moller MH, Clausen JB, Schack Frederiksen IM, Olsen L, Javidi M, Vilhelmsen J, Olsen MK, Biering-Sorensen B. Home-Based Titration with Duodenal Infusion of Levodopa-Carbidopa Intestinal Gel in People with Parkinson's Disease: An Observational Feasibility Study. Parkinsons Dis. 2024 Apr 8;2024:5522824. doi: 10.1155/2024/5522824. eCollection 2024. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 2 month |
| Montreal Cognitive Assesment (MOCA) | Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction. | 2 month |
| Parkinsons Disease Questionnaire 39 (PD-Q39) | 39 questions for the patients to rate QoL in Parkinson's Disease. | 2 month |
| Unified Parkinsons Disease Rating Scale III (UPDRS) | Scale on assesment of severity of disease induced symptoms. A total of 199 points represents the worst (total) disability. | 2 month |
| Barthel-20 index | Version 30/11-2017, Maximum score 20. | 2 month |
| Non-Motor Symptom Scale (NMSS) | 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |