Bringing Parkinson Care Back Home

Study Overview
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Brief Summary
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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.

Official Title
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Bringing Parkinson Care Back Home

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable sensors, Falls, Physical activity, Parkinson's disease