Guideline for Hometitration With Duodopa for Parkinson Patients

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT04196647
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients not eligible for Duodopa-treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	14 days after titration	Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinsons Disease Rating Scale III (UPDRS)	2 month	Scale on assesment of severity of disease induced symptoms. A total of 199 points represents the worst (total) disability.
Hoehn Yahr staging of Parkinson's disease	2 month	Scale to acces severity of symptoms of Parkinsons disease.; 1. Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement; 2. Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test; 3. Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent; 4. Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted; 5. Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided
Montreal Cognitive Assesment (MOCA)	2 month	Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction.
Parkinsons Disease Questionnaire 39 (PD-Q39)	2 month	39 questions for the patients to rate QoL in Parkinson's Disease.
Barthel-20 index	2 month	Version 30/11-2017, Maximum score 20.
Non-Motor Symptom Scale (NMSS)	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.

Trial Locations

Locations (1)

Neurologisk klinik, Rigshospitalet Glostrup; 🇩🇰 Copenhagen, Glostrup, Denmark