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 Type
OBSERVATIONAL
Enrollment
200
Radboud university medical center
Nijmegen, Netherlands
Falls
Number of alls measured with wearable sensors
Time frame: Continuously over 12 months
Physical activity
Minutes of physical activity performed during daily-life measured with wearable sensors
Time frame: Continuously over 12 months
Physical activity
LASA physical activity questionnaire, in which the higher the score the better
Time frame: Twice - baseline and after 12 months
Walking capacity
6-meter walking test, in which the higher the distance walked the better
Time frame: Once - baseline
Falls
Falls history questionnaire
Time frame: 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
Time frame: 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
Time frame: Twice - baseline and after 12 months
Compliance
Number of days in which participants worn the device for more than 8 hours
Time frame: Continuously over 12 months
Patients demographics
Demographics questionnaire (age, gender, education, disease duration)
Time frame: 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.
Time frame: 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.
Time frame: Once - baseline
Medication
Medication intake diary
Time frame: Continuously over 12 months
Balance - I
Mini-BESTest, ranging from 0 to 28, in which the higher the score the better the balance
Time frame: Once - baseline
Balance - II
Single leg stance test
Time frame: 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.
Time frame: Twice - baseline and after 12 months
Freezing of gait - II
Rapid turns test
Time frame: Once - baseline
Cognition
Montreal Cognitive Assessment, with scores ranging from 0 to 30, in which the higher the better the cognition.
Time frame: Once - baseline
Sleep quality
Pittsburgh Sleep Quality Index, with scores ranging from 0 to 21, in which the higher the worse the sleep quality.
Time frame: Twice - baseline and after 12 months
Sleep quality and quantity
Sleep diary
Time frame: Once for a full week
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