Guideline for Hometitration With Duodopa for Parkinson Patients

October 31, 2022 updated by: Bo Biering-Soerensen, Rigshospitalet, Denmark

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

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"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Neurologisk Klinik, Rigshospitalet Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced parkinson, reffered to Duodopa treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 14 days after titration
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
Time Frame: 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
2 month
Montreal Cognitive Assesment (MOCA)
Time Frame: 2 month
Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction.
2 month
Parkinsons Disease Questionnaire 39 (PD-Q39)
Time Frame: 2 month
39 questions for the patients to rate QoL in Parkinson's Disease.
2 month
Unified Parkinsons Disease Rating Scale III (UPDRS)
Time Frame: 2 month
Scale on assesment of severity of disease induced symptoms. A total of 199 points represents the worst (total) disability.
2 month
Barthel-20 index
Time Frame: 2 month
Version 30/11-2017, Maximum score 20.
2 month
Non-Motor Symptom Scale (NMSS)
Time Frame: 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.
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Bo Biering-Sørensen, Director, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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