Clinical trial NCT04196647: Guideline for Hometitration With Duodopa for Parkinson Patients
Official title: Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson disease
duodopa
pump
tele-medicine
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2019-12-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced parkinson, reffered to Duodopa treatment.

Brief summary: 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"

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 14 days after titration
Secondary outcomes:
measure: Hoehn Yahr staging of Parkinson's disease
timeFrame: 2 month
measure: Montreal Cognitive Assesment (MOCA)
timeFrame: 2 month
measure: Parkinsons Disease Questionnaire 39 (PD-Q39)
timeFrame: 2 month
measure: Unified Parkinsons Disease Rating Scale III (UPDRS)
timeFrame: 2 month
measure: Barthel-20 index
timeFrame: 2 month
measure: Non-Motor Symptom Scale (NMSS)
timeFrame: 2 month
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neurologisk klinik, Rigshospitalet Glostrup
state: Glostrup
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bo Biering-Sørensen, Director
role: PRINCIPAL_INVESTIGATOR
References: