Bringing Parkinson Care Back Home
- Conditions
- Parkinson Disease
- Registration Number
- NCT04288583
- Lead Sponsor
- Radboud University Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Falls Continuously over 12 months Number of alls measured with wearable sensors
Physical activity Continuously over 12 months Minutes of physical activity performed during daily-life measured with wearable sensors
- Secondary Outcome Measures
Name Time Method Falls Twice - baseline and after 12 months Falls history questionnaire
Medication Continuously over 12 months Medication intake diary
Physical activity Twice - baseline and after 12 months LASA physical activity questionnaire, in which the higher the score the better
Patients demographics Once - baseline Demographics questionnaire (age, gender, education, disease duration)
Disease status Once - baseline Hoehn \& Yahr stadia, ranging from 0-5, in which the higher the worse the disease status is.
Functional lower extremity strength Once - baseline Five-times-sit-to-stand, in which the faster the task is completed the better
Disease severity Part III - once at baseline. Part I, II and IV - twice baseline and after 12 months 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.
Freezing of gait - II Once - baseline Rapid turns test
Walking capacity Once - baseline 6-meter walking test, in which the higher the distance walked the better
Balance - I Once - baseline Mini-BESTest, ranging from 0 to 28, in which the higher the score the better the balance
Sleep quality Twice - baseline and after 12 months Pittsburgh Sleep Quality Index, with scores ranging from 0 to 21, in which the higher the worse the sleep quality.
Sleep quality and quantity Once for a full week Sleep diary
Fear of falling Twice - baseline and after 12 months Falls Efficacy Scale International, with scores ranging from 16 to 64 points, in which the a higher score indicates worse fear of falling
Compliance Continuously over 12 months Number of days in which participants worn the device for more than 8 hours
Balance - II Once - baseline Single leg stance test
Freezing of gait - I Twice - baseline and after 12 months New freezing of gait questionnaire, ranging from 0 to 24, in which the higher the score the worse is the freezing of gait.
Cognition Once - baseline Montreal Cognitive Assessment, with scores ranging from 0 to 30, in which the higher the better the cognition.
Trial Locations
- Locations (1)
Radboud university medical center
🇳🇱Nijmegen, Netherlands