Parkinson's Disease Inpatient Clinical Knowledge and Management

NCT03888287 | Terminated Results FDA Device

• 1 other identifier: Pro00006159
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

PICK study; Impact of Watch Rx

Outcome Measures

Primary Outcomes (1)

• Clinician's Parkinson's Disease Knowledge Assessment Survey Scores

  Clinician's Parkinson's Disease Knowledge Assessment Survey scores before and after the Parkinson's Disease Inpatient Clinical Knowledge and Management Program. A 20-question survey was administered to PD clinicians for a group measurement of PD knowledge. Scores ranged from 0 - 100% and reflected the percentage of clinicians who correctly answered the question. If 70% or more clinicians correctly answered the question, the group was considered knowledgeable on that topic; if \<70% of clinicians responded incorrectly, they were considered not knowledgeable on the information that the question assessed. Survey questions addressed three PD areas: 1) medication/treatment, 2) symptoms/diagnosis, and 3) epidemiology/pathophysiology.

  6 months

Secondary Outcomes (8)

• Number of PD Medications Administered on Time (15 Minute Window)

  within 15 minutes post PD medication administration time

• Number of Patients With Contraindicated Medications Administered.

  6 months

• Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog

  6 Months

• Length of Stay in Hospitalized Parkinson's Disease Patients.

  6 months

• Number of PD Medications Administered on Time (Within 15 Minute Window)

  15 minutes post assigned medication administration time.

Study Arms (4)

Retrospective Phase

EXPERIMENTAL

Patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.

Device: Watch Rx system

Prospective Phase-Watch Rx system

EXPERIMENTAL

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; Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program

Retrospective Phase - Clinicians

EXPERIMENTAL

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

Prospective Phase - Clinicians

EXPERIMENTAL

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

Interventions

Watch Rx system DEVICE

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

Prospective Phase-Watch Rx system; Retrospective Phase

Parkinson's Disease Inpatient Clinical Knowledge and Management Program OTHER

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

Prospective Phase - Clinicians; Prospective Phase-Watch Rx system; Retrospective Phase - Clinicians

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Prospective enrollment did not occur due to the COVID-19 pandemic, patients were not admitted for elective surgeries. Results of the clinician education were only reported in aggregate.

Results Point of Contact

• Title: Hooman Azmi, MD
• Organization: Hackensack Meridian Health

hooman.azmi@hmhn.org

201-342-2550

Study Officials

• Azmi Hooman, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

• Mohammed Quadri, MD, MBA

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: March 25, 2019
• Study Start: August 1, 2018
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: April 18, 2023
• Results First Posted: March 16, 2023

Record last verified: 2023-03

Locations

US (1)