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Parkinson's Disease Inpatient Clinical Knowledge and Management (PICK)

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ClinicalTrials.gov Identifier: NCT03888287
Recruitment Status : Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Study Description
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Brief Summary:
This study will focus on patients with Parkinson's Disease in the adult inpatient units of Hackensack University Medical Center. We are measuring the effect of a Parkinson's Disease Inpatient Clinical Knowledge and Management Program on adherence to Parkinson's Disease medication using a Parkinson's Disease Identification Wrist Band, smartwatch and medication schedule card

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Watch Rx system Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The WatchRx is a smartwatch worn on the patient's wrist which receives alerts and notifications for medication administration scheduling as well as intervention messages from a App to the caregiver
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Parkinson's Disease Inpatient Clinical Knowledge and Management
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Retrospective Phase
150 patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
 Device: Watch Rx system
The Watch Rx system consists of a Watch Rx smartwatch, Watch Rx application and a WatchRx Web Interface. The Watch Rx smartwatch will be worn on the patient's wrist. The smart watch will send alerts to the caregivers through the Watch Rx app when it is time to administer the medication. The Web Interface will be used to store the medical documentations
Experimental: Prospective Phase-Watch Rx system
150 patients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system
 Device: Watch Rx system
The Watch Rx system consists of a Watch Rx smartwatch, Watch Rx application and a WatchRx Web Interface. The Watch Rx smartwatch will be worn on the patient's wrist. The smart watch will send alerts to the caregivers through the Watch Rx app when it is time to administer the medication. The Web Interface will be used to store the medical documentations
Experimental: Retrospective Phase - Clinicians
346 clinicians, including physician's assistant, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapist and occupational therapist before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
 Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program
Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients
Experimental: Prospective Phase - Clinicians
346 clinicians, including physician's assistant, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapist and occupational therapist after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
 Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program
Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients


Outcome Measures
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Primary Outcome Measures :
  1. Compare the Parkinson's Disease Inpatient Clinical Knowledge of clinicians before and after the Parkinson's Disease Inpatient Clinical Knowledge and Management Program [ Time Frame: 1 year ]
    Examine the effectiveness of Parkinson's Disease Inpatient Clinical Knowledge and Management Program on PD medication management using a Parkinson's Disease Knowledge Assessment Survey

  2. Evaluate the Impact of WatchRx system on PD medication adherence during hospitalization [ Time Frame: 6 months ]
    Track number of medication errors as measured by difference in actual and scheduled PD medication administration time and the number of contraindicated medication administrations.

  3. Track adverse events in hospitalized patients [ Time Frame: 6 months ]
    Track adverse events (including number of falls, number of falls with injury, number of patients with positive CAM/Mini-Cog scores, and length of stay) in hospitalized patients before and after implementation of Parkinson's Disease Inpatient Clinical Knowledge and Management Program and the WatchRx system.


Secondary Outcome Measures :
  1. Patients with Early Identification of Parkinson's Disease [ Time Frame: 6 Months ]
    number of patients with early identification of Parkinson's Disease

  2. Patients Enrolled in Parkinson's Disease Registry at HackensackUMC [ Time Frame: 6 Months ]
    Parkinson's Disease Registry

  3. Trend the prevalence of Parkinson's Disease patients at HackensackUMC [ Time Frame: 6 Months ]
    Identify a trend


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients diagnosed with primary and secondary diagnosis of Parkinson's disease
  • Patient 22 years old and older
  • Patients admitted to inpatient units
  • Patient who are verbally informed and agree to participate in the study

Exclusion Criteria:

  • Patients less than or equal to 21 years of age
  • Patients who refuse to wear the PD wrist band.
  • Patients who verbally refuse enrollment in the PD registry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888287


Locations
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United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Azmi Hooman, MD Hackensack Meridian Health
Principal Investigator: Mohammed Quadri, MD, MBA Hackensack Meridian Health
Principal Investigator: Claudia Douglas, DNP Hackensack Meridian Health
More Information
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03888287     History of Changes
Other Study ID Numbers: Pro00006159
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hackensack Meridian Health:
PICK study
Impact of Watch Rx

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases