Bringing Parkinson Care Back Home

Parkinson Disease Clinical Trial

Official title:

Bringing Parkinson Care Back Home

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04288583
• Other study ID #: 2019-5845
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Number of alls measured with wearable sensors	Continuously over 12 months
Primary	Physical activity	Minutes of physical activity performed during daily-life measured with wearable sensors	Continuously over 12 months
Secondary	Physical activity	LASA physical activity questionnaire, in which the higher the score the better	Twice - baseline and after 12 months
Secondary	Walking capacity	6-meter walking test, in which the higher the distance walked the better	Once - baseline
Secondary	Falls	Falls history questionnaire	Twice - baseline and after 12 months
Secondary	Functional lower extremity strength	Five-times-sit-to-stand, in which the faster the task is completed the better	Once - baseline
Secondary	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
Secondary	Compliance	Number of days in which participants worn the device for more than 8 hours	Continuously over 12 months
Secondary	Patients demographics	Demographics questionnaire (age, gender, education, disease duration)	Once - baseline
Secondary	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
Secondary	Disease status	Hoehn & Yahr stadia, ranging from 0-5, in which the higher the worse the disease status is.	Once - baseline
Secondary	Medication	Medication intake diary	Continuously over 12 months
Secondary	Balance - I	Mini-BESTest, ranging from 0 to 28, in which the higher the score the better the balance	Once - baseline
Secondary	Balance - II	Single leg stance test	Once - baseline
Secondary	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
Secondary	Freezing of gait - II	Rapid turns test	Once - baseline
Secondary	Cognition	Montreal Cognitive Assessment, with scores ranging from 0 to 30, in which the higher the better the cognition.	Once - baseline
Secondary	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
Secondary	Sleep quality and quantity	Sleep diary	Once for a full week