Bringing Parkinson Care Back Home

NCT04288583 | Unknown

• 1 other identifier: 2019-5845
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Wearable sensors; Falls; Physical activity; Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Physical activity

  Twice - baseline and after 12 months

• Walking capacity

  Once - baseline

• Falls

  Twice - baseline and after 12 months

• Functional lower extremity strength

  Once - baseline

• Fear of falling

  Twice - baseline and after 12 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Nienke M de Vries, Dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: March 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 4, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After study completion.
• Access Criteria: Access to the data will be granted for those performing research about Parkinson's disease.

Locations

NL (1)