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Completed

NCT Number: NCT04196647

Guideline for Hometitration With Duodopa for Parkinson Patients

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"

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurologisk klinik, Rigshospitalet Glostrup

Copenhagen, Glostrup, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home titration

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hoehn Yahr staging of Parkinson's disease

    Time frame: 2 month

    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. Montreal Cognitive Assesment (MOCA)

    Time frame: 2 month

    Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction.

  3. Parkinsons Disease Questionnaire 39 (PD-Q39)

    Time frame: 2 month

    39 questions for the patients to rate QoL in Parkinson's Disease.

  4. 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.

  5. Barthel-20 index

    Time frame: 2 month

    Version 30/11-2017, Maximum score 20.

  6. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • AbbVie

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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