Clinical trial NCT04288583: Bringing Parkinson Care Back Home
Official title: Bringing Parkinson Care Back Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Wearable sensors
Falls
Physical activity
Parkinson's disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Falls
timeFrame: Continuously over 12 months
measure: Physical activity
timeFrame: Continuously over 12 months
Secondary outcomes:
measure: Physical activity
timeFrame: Twice - baseline and after 12 months
measure: Walking capacity
timeFrame: Once - baseline
measure: Falls
timeFrame: Twice - baseline and after 12 months
measure: Functional lower extremity strength
timeFrame: Once - baseline
measure: Fear of falling
timeFrame: Twice - baseline and after 12 months
measure: Compliance
timeFrame: Continuously over 12 months
measure: Patients demographics
timeFrame: Once - baseline
measure: Disease severity
timeFrame: Part III - once at baseline. Part I, II and IV - twice baseline and after 12 months
measure: Disease status
timeFrame: Once - baseline
measure: Medication
timeFrame: Continuously over 12 months
measure: Balance - I
timeFrame: Once - baseline
measure: Balance - II
timeFrame: Once - baseline
measure: Freezing of gait - I
timeFrame: Twice - baseline and after 12 months
measure: Freezing of gait - II
timeFrame: Once - baseline
measure: Cognition
timeFrame: Once - baseline
measure: Sleep quality
timeFrame: Twice - baseline and after 12 months
measure: Sleep quality and quantity
timeFrame: Once for a full week
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: Radboud University Medical Center
name: Nienke M de Vries, Dr
role: PRINCIPAL_INVESTIGATOR
References: