Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284629
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-02-14
Brief Title:
Enhancing Referral Decision-making for Advanced Treatment in Parkinsons Disease Through Objective Measurements and Patient Reported Outcomes
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
PD-DigiCare Enhancing Referral Decision-making for Advanced Treatment in Parkinsons Disease Through Objective Measurements and Patient Reported Outcomes - a Multicentre Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PD-DigiCare
Brief Summary:
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 Parkinsons Disease
Detailed Description:
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 Parkinsons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None