Bringing Parkinson Care Back Home

SUMMARY

Rationale: For persons with Parkinson's disease (PD), medical decisions are based almost exclusively on periodic in-clinic evaluations by a neurologist or a nurse. For a variety of reasons, such "snapshots" are unable to capture the actual impact of PD on the patient's functioning in their own home environment. Outpatient evaluations cannot detect rare and typically domestic events, such as falls. In addition, episodic visits are not well suited to detect changes in important lifestyle issues, such as gradual declines in physical activity.

Objective: To objectively, continuously and accurately collect detailed information on (changes in) physical activity and fall patterns among patients with PD in daily life.

Study design: Observational cohort study in 200 patients with PD, with a 12 month follow-up period.

Study population: Patients with PD (n=200), with an increased fall risk (i.e. at least one fall within the last six months).

Intervention (if applicable): This study does not include an intervention. After a baseline assessment on demographics and PD symptoms, patients will use a remote monitoring system at home (a pendant falls detector) combined with an smartphone application aimed at falls self-reporting, and an application to report medication intake for 12 months. A similar set up (i.e.Vital@Home) has been previously tested on feasibility (Dossiernummer: 2017-3382). Additionally, patients will report sleep patterns through paper-based diaries.

Main study parameters/endpoints: The main study parameters are physical activity and number of falls. They are remotely registered by the pendant falls detector.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no invasive measurements will be performed. The participation is free of risks. Subjects could potentially benefit personally from participating in this study, as they can use the devices for free during the study and receive periodically feedback about physical activity and the occurrence of falls.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 patients diagnosed with Parkinson's disease with an increased fall risk (i.e. who reported at least one fall in the last 6 months).

Description

Inclusion Criteria:

• Subjects must confirm that they have been diagnosed with Parkinson's Disease by a neurologist (self-reported)
• Age 18 or older
• At least 1 fall incident in the previous 6 months. A fall is defined as any unexpected event that caused the person to unintentionally land on any lower surface (object, floor, or ground), regardless of any sustained injury (self-reported)
• Able and willing to provide written informed consent in accordance with Good Clinical Practice, and national and local regulation
• Fluent in Dutch

Exclusion Criteria:

• The patients receives advanced therapy for their Parkinson's disease (deep brain stimulation, duodopa pump, apomorphine pump);
• The patients shows cognitive of psychiatric impairments that may hinder successful completion of the study protocol (as judged by the researcher running the recruitment).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Number of alls measured with wearable sensors	Continuously over 12 months
Physical activity	Minutes of physical activity performed during daily-life measured with wearable sensors	Continuously over 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	LASA physical activity questionnaire, in which the higher the score the better	Twice - baseline and after 12 months
Walking capacity	6-meter walking test, in which the higher the distance walked the better	Once - baseline
Falls	Falls history questionnaire	Twice - baseline and after 12 months
Functional lower extremity strength	Five-times-sit-to-stand, in which the faster the task is completed the better	Once - baseline
Fear of falling	Falls Efficacy Scale International, with scores ranging from 16 to 64 points, in which the a higher score indicates worse fear of falling	Twice - baseline and after 12 months
Compliance	Number of days in which participants worn the device for more than 8 hours	Continuously over 12 months
Patients demographics	Demographics questionnaire (age, gender, education, disease duration)	Once - baseline
Disease severity	Movement Disorders Society - Unified Parkinson's Disease Rating Scale part I-IV, with scores ranging from 0 to 272, in which the higher the score the worse symptoms are.	Part III - once at baseline. Part I, II and IV - twice baseline and after 12 months
Disease status	Hoehn & Yahr stadia, ranging from 0-5, in which the higher the worse the disease status is.	Once - baseline
Medication	Medication intake diary	Continuously over 12 months
Balance - I	Mini-BESTest, ranging from 0 to 28, in which the higher the score the better the balance	Once - baseline
Balance - II	Single leg stance test	Once - baseline
Freezing of gait - I	New freezing of gait questionnaire, ranging from 0 to 24, in which the higher the score the worse is the freezing of gait.	Twice - baseline and after 12 months
Freezing of gait - II	Rapid turns test	Once - baseline
Cognition	Montreal Cognitive Assessment, with scores ranging from 0 to 30, in which the higher the better the cognition.	Once - baseline
Sleep quality	Pittsburgh Sleep Quality Index, with scores ranging from 0 to 21, in which the higher the worse the sleep quality.	Twice - baseline and after 12 months
Sleep quality and quantity	Sleep diary	Once for a full week

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Nienke M de Vries, Dr, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Physical activity; Parkinson's disease; Wearable sensors; Falls
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2019-5845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be anonymized. The wearable sensor data will not be available for re-use and/or sharing.
• IPD Sharing Time Frame: After study completion.
• IPD Sharing Access Criteria: Access to the data will be granted for those performing research about Parkinson's disease.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No