Guideline for Hometitration With Duodopa for Parkinson Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Home titration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Home titration|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoehn Yahr staging of Parkinson's disease | Scale to acces severity of symptoms of Parkinsons disease. Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, duodopa, pump, tele-medicine