Brief Summary

Background: Long-term management of Parkinson's disease (PD) does not reach its full potential due to lack of knowledge about disease progression. The Real-PD study aim to evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real life. Moreover, an explorative analysis concerning activity level, medication intake and mood will be done. Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this observational study. Dutch PD patients will be recruited across the country and an assessment will be performed using a short version of the Parkinson's Progression Markers Initiative (PPMI) protocol. Moreover, participants will wear a set of medical devices (Pebble Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App (Android app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical activity, falls and tremor, measured by the axial accelerometers embedded in the Pebble watch and fall detector; and 2) medication intake and mood reports measured by patients' self-report in the Android app. To measure motor impact, an assessment will be performed by physiotherapists who are all certified to perform the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Discussion: Management of PD patients is complex and appears to be a challenging task for health care professionals. The main reason is the lack of knowledge in the disease pattern. This issue could be solved by a long term follow-up of patients' during their everyday life, and wearable medical devices can act as a way to collect data about every day life activities. Therefore, the Real-PD study will be a first contribution in increasing the lack of knowledge in disease progression, developing a new medical decision system and improving PD patients' care.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

304

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2015

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

June 2, 2015

Completed

15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed

14 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

December 6, 2021

Completed

Last Updated

December 6, 2021

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

June 2, 2015

Results QC Date

January 7, 2021

Last Update Submit

October 28, 2021

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseAmbulatory monitoringDisease progression

Outcome Measures

Primary Outcomes (4)

Parkinson's Disease Symptoms
The MDS-UPDRS is a revision of the Unified Parkinson's Disease Rating Scale (UPDRS). It was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living, as well as motor complications. The MDS-UPDRS characterizes the extent and burden of disease across various populations. Here, we used data from one-point assessment (baseline). The total score used here was calculated by a sum of all scores from the 4 sub-scales (i.e. part I, up to part IV) composing the MDS-UPDRS. Total score ranges from 0 to 272. A higher score indicates higher disease severity and burden, being thus a worse outcome.
Baseline
Depression Scores as a Measure of Depression Rates
The scores obtained with the Geriatric Depression Scale were analysed in order to create a percentage of probably depressed participants. The total score goes from 0 to 15. A score higher than 6 indicates higher probability of suffer from a depression.
Baseline
Cognitive Impairment.
Total sum score obtained with the Montreal Cognitive Assessment. We analyzed the full score to investigate percentage of participants with a possible cognitive impairment. The Montreal Cognitive sum scores ranges from 0 to 30, in which a score lower or equal to 26 is considered as possible cognitive decline.
Baseline
Independency Level
The total sum score obtained with the Schwab and England activities of daily living scale were analyzed to describe the functional level of the sample. The total sum scores varies from 0 to 100, in which lower scores are associated with more dependency of others to perform daily life activities.
Baseline

Secondary Outcomes (7)

Number of Falls Per Patient Registered by the Falls Detector.
Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week.
Number of Mood Reports for Each Patient Measured With a Four Point Scale
Patients will be assessed during the follow-up time (up to 13 weeks after the enrollment date). It is expected that the assessment (self-report) will be performed as many times as the patient wants to report how they feel or at least once a day.
Number of Medication Intake Annotations Made by Each Participant Via the Self-report App.
Baseline
Time That Each Patient Was Active During the Day
Patients will be automatically assessed continuously during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week. The analyses was limited to walking activities.
Level of Activity for Each Patient During the Day
Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week.
+2 more secondary outcomes

Study Arms (5)

Cohort 1

Dutch Parkinson's patients resident in the region of Noord-Holland whose fulfill the eligibility criteria. Interventions/Exposures to be administered: 1. PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once. 2. Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling.