Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.

Официальное название

PD-DigiCare: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes - a Multicentre Randomized Controlled Trial.

Обзор

The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease.

Подробное описание

The study is a multicentre, parallel group, randomized controlled trial, investigating the value of using wearable devices and electronic patient-reported outcome measurements to improve clinical decision-making related to people with Parkinson's Disease.

Data from a wearable device and a mobile app will be compared to current standard of care.

90 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and Odense University Hospital (OUH), as well as from 5 private practice neurologists in Denmark. They will equally be randomized to one of two groups: Intervention or Standard of Care.

Each participant will take part of the trial for one year, in which they will have 5 study visits:

* Baseline * Clinical visits every 3 months (months 3, 6 and 9) * Final visit after 12 months

They will be asked to wear the device and report symptoms in the app for one year. We will then compare decisions made related to changes in medication and referrals to advanced treatment.

Вмешательства

• Устройство Neptune
  Neptune is a software algorithm that utilizes data from wrist-worn sensors to track Parkinson motor symptoms and displays them in an easy to understand graph. Neptune Care is a mobile app that includes a patient portal, where patients can self-report symptoms, view their motor data and get medication reminders, and a physician portal, where the treating physician can view the objective motor data and patient-reported outcomes prior to a clinical visit.
• Другое Standard clinical care
  Treatment and management according to standard clinical care

Первичные конечные точки

• Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment. [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]
• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]
• Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale) [Срок оценки: 1 year]
• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]
• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]
• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]
• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Diagnosed with Idiopathic Parkinson's Disease
• Taking five or more doses of levodopa daily
• Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia.
• Able to utilize a digital product, either alone or assisted by a caregiver.

Критерии исключения

• Consistent use of a wheelchair or walker which may interfere significantly with the remote monitoring of PD motor symptoms.
• Lack of understanding and proficiency in the Danish language.
• Inability to use wearable devices due to non-compliance, physical and/or skin sensitivity.
• Suffering from severe psychiatric disorders.
• Otherwise not qualified to receive advanced treatment (e.g., advanced cancer, severe heart failure).
• Already undergoing advanced treatment.
• Diagnosed with atypical or secondary parkinsonism.
• Other patient groups otherwise deemed ineligible by the project manager.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Rigshospitalet Glostrup — Glostrup Municipality
• Odense University Hospital — Odense

Идентификаторы

NCT: NCT06284629 · PD-DigiCare

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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