Guideline for Hometitration With Duodopa for Parkinson Patients

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196647
• Other study ID #: 15010036
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Denmark	Neurologisk klinik, Rigshospitalet Glostrup	Copenhagen	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	AbbVie

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Montreal Cognitive Assesment (MOCA)	Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction.	2 month
Secondary	Parkinsons Disease Questionnaire 39 (PD-Q39)	39 questions for the patients to rate QoL in Parkinson's Disease.	2 month
Secondary	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
Secondary	Barthel-20 index	Version 30/11-2017, Maximum score 20.	2 month
Secondary	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