Parkinson DiseasePICKNCT03888287
Parkinson's Disease Inpatient Clinical Knowledge and Management
A study testing Watch Rx system and Parkinson's Disease Inpatient Clinical Knowledge and Management Program in people with Parkinson Disease, run by Hackensack Meridian Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Watch Rx system and Parkinson's Disease Inpatient Clinical Knowledge and Management Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 3 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
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
Read the detailed description
Parkinson's Disease (PD), the second-most common neurodegenerative disorder and is ranked the fourteenth leading cause of death. PD prevalence rate in the United States is estimated to be approximately 0.3% and is ranked the fourteenth leading cause of death (CDC, 2013). Depending on the methodology, the national prevalence data on PD is varied and insufficient. PD is projected to increase by 4% to 5% in age 65 and over 85 years respectively and is associated with a high economic burden exceeding $14.4 billion per year.
Admission to the hospital is identified as a major risk factor due to imprecise timing of medication administration, disruption of sleep pattern, dietary changes, and unfamiliarity of the hospital environment which all contribute to the exacerbation of PD symptoms. Parkinson's disease Foundation, 2015). Hospital length of stay for patients with PD is 1.45 times higher in comparison to non- PD patients.
A study by Chou et al., (2011) involving 51 worldwide National Parkinson Foundation Centers found 94% of centers were not confident in the care and knowledge hospital professionals provided specific to: PD medications, complex drug interactions, contraindications and precise timing of medication administration. Hospital co-morbidities could be improved or prevented by adjustment of PD medication and medication adherence, critical in decreasing hospital length of stay.
The retrospective phase will be a data collection of adult patients admitted with a primary and secondary diagnosis of Parkinson's disease during January - June 2015 (6 month period). There will be 150 patients selected by the principal investigator(s) from chart review. In addition, the clinicians chosen for the study will complete a Parkinson's Disease Knowledge Assessment Survey.
The prospective phase will begin after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program for staff nurses, advanced practice nurses (APN), nursing assistants, patient care technicians, case managers, adult inpatient physician assistants, pharmacists, occupational therapists, physical therapists, nurse educators, and dietitians. There will be 150 patients selected from the adult inpatient units by the principal investigator(s) that meet the inclusion criteria and confirm through an informed consent that they will participate in the study.
The selected patients will be registered in a WatchRx interface via website URL by the Principal Investigator(s) and the Transition of Care(TC) Pharmacist and required to wear a Watch Rx smartwatch for the duration of their hospitalization. The Watch Rx Interface will store all medical information, necessary treatments, and daily clinical care for the patient which is synchronized to the smartwatch on the patient's wrist. The smartwatch will send alerts to the patient's assigned nurse's iPad through a Watch Rx app for medication administration, missed PD medications, battery conditions, and enables messaging between the primary nurse and the patient.
The WatchRx smartwatch will remind when it is time to take the medication. If the Parkinson's Disease medication is not administered, it sends missed medication reminder alerts to the nurse. For fixed time medication, the reminder is every 3 minutes up to 10 minutes.
During the prospective phase, the research team will collect data from multiple sources such as the Watch Rx system, EPIC Hyperspace, and Case Report forms over a 6 month study period. The data will be calculated by using statistical analysis for the continuous variables and categorical variables identified from the collection of data. All study data will be imported into SAS software where data programming will be utilized to flag and generate queries on out-of-range data issues until they are resolved. All analysis will be performed using SAS version 9.4 (SAS Institute Inc. Cary, North Carolina, USA Data will be handled in a confidential manner to meet mandated IT Security standards and to prevent loss of privacy. All electronic files will be stored in an encrypted and password-protected database on a secure medical center server. Only co-investigators, advanced practice nurses, and the data coordinator who contact the subjects will have access to information linked to subject identifiers.
This study will improve timely administration of medications to PD patients. Patients enrolled in the study will have direct monitoring of their medication compliance and adherence. Patients participating in the registry will be gain information from the current research and possibly create a support group amongst themselves. This study will improve knowledge of Parkinson's disease amongst clinicians and better medication management of PD patients
- Conditions
- Parkinson Disease
- Being tested
- Watch Rx system, Parkinson's Disease Inpatient Clinical Knowledge and Management Program
- Keywords
- PICK study, Impact of Watch Rx
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watch Rx systemDevice
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
Parkinson's Disease Inpatient Clinical Knowledge and Management ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Phase | Experimental | Patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program. Receives: 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 Receives: 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. Receives: 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. Receives: Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
Number of PD Medications Administered on Time (15 Minute Window)
The number of Parkinson's Disease (PD) medications administered within the 15-minute timeframe at baseline
Measured: within 15 minutes post PD medication administration time
Number of Patients With Contraindicated Medications Administered.
Measure the number of patients who were adminstered contraindicated medications
Measured: 6 months
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
The number of falls, number of falls with injury, and number of patients with positive Confusion Assessment Method (CAM)/Mini-Cog scores) in hospitalized patients.
Mini-cog is performed on all admitted patients 65 years and older and is a quick screening for "cognitive vital sign" and early dementia detection. The scale classifies patients as being positive or negative for dementia.
The Confusion Assessment Method (CAM) is performed on all adult admissions at the time of admission with reporting 1) every shift if the first test is positive, or 2) daily if the first test is negative. It improves the detection and recognition of delirium accurately and quickly in clinical and research settings. CAM is documentation of observed patient behavior during brief, structured interviews according to classification of positive or negative for dementia. There are no numerical (minimum or maximum) values assigned.
Measured: 6 Months
Length of Stay in Hospitalized Parkinson's Disease Patients.
Average length of stay in hospitalized Parkinson's Disease patients
Measured: 6 months
Number of PD Medications Administered on Time (Within 15 Minute Window)
Track the difference that the WatchRx system has on scheduled PD medication administration time versus actual PD medication administration time
Measured: 15 minutes post assigned medication administration time.
Number of PD Medication Errors After Using the WatchRX System
The number of contraindicated medications administered to Parkinson's disease patients after using the WatchRX system
Measured: 6 Months
Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System
The number of falls, number of falls with injury, number of positive CAM scores, and number of positive Mini-Cog scores after using the WatchRX system.
Measured: 6 months
Length of Stay With the WatchRx System
Parkinson's disease patients' length of stay after using the WatchRx system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Aug 2018
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Why it stopped: Study was put on hold due to COVID and never reopened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azmi Hooman, MD, Principal investigator, Hackensack Meridian HealthMohammed Quadri, MD, MBA, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888287
- Sponsor's protocol ID
- Pro00006159
- Acronym
- PICK
- Status last verified
- Mar 2023
- First submitted
- 1 Aug 2018
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease Inpatient Clinical Knowledge and Management
- ClinicalTrials.gov ID
- NCT03888287
- Acronym / sponsor ID
- PICK / Pro00006159
- Conditions
- Parkinson Disease
- Keywords
- PICK study, Impact of Watch Rx
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was put on hold due to COVID and never reopened
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 16 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Parkinson's Disease (PD), the second-most common neurodegenerative disorder and is ranked the fourteenth leading cause of death. PD prevalence rate in the United States is estimated to be approximately 0.3% and is ranked the fourteenth leading cause of death (CDC, 2013). Depending on the methodology, the national prevalence data on PD is varied and insufficient. PD is projected to increase by 4% to 5% in age 65 and over 85 years respectively and is associated with a high economic burden exceeding $14.4 billion per year.
Admission to the hospital is identified as a major risk factor due to imprecise timing of medication administration, disruption of sleep pattern, dietary changes, and unfamiliarity of the hospital environment which all contribute to the exacerbation of PD symptoms. Parkinson's disease Foundation, 2015). Hospital length of stay for patients with PD is 1.45 times higher in comparison to non- PD patients.
A study by Chou et al., (2011) involving 51 worldwide National Parkinson Foundation Centers found 94% of centers were not confident in the care and knowledge hospital professionals provided specific to: PD medications, complex drug interactions, contraindications and precise timing of medication administration. Hospital co-morbidities could be improved or prevented by adjustment of PD medication and medication adherence, critical in decreasing hospital length of stay.
The retrospective phase will be a data collection of adult patients admitted with a primary and secondary diagnosis of Parkinson's disease during January - June 2015 (6 month period). There will be 150 patients selected by the principal investigator(s) from chart review. In addition, the clinicians chosen for the study will complete a Parkinson's Disease Knowledge Assessment Survey.
The prospective phase will begin after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program for staff nurses, advanced practice nurses (APN), nursing assistants, patient care technicians, case managers, adult inpatient physician assistants, pharmacists, occupational therapists, physical therapists, nurse educators, and dietitians. There will be 150 patients selected from the adult inpatient units by the principal investigator(s) that meet the inclusion criteria and confirm through an informed consent that they will participate in the study.
The selected patients will be registered in a WatchRx interface via website URL by the Principal Investigator(s) and the Transition of Care(TC) Pharmacist and required to wear a Watch Rx smartwatch for the duration of their hospitalization. The Watch Rx Interface will store all medical information, necessary treatments, and daily clinical care for the patient which is synchronized to the smartwatch on the patient's wrist. The smartwatch will send alerts to the patient's assigned nurse's iPad through a Watch Rx app for medication administration, missed PD medications, battery conditions, and enables messaging between the primary nurse and the patient.
The WatchRx smartwatch will remind when it is time to take the medication. If the Parkinson's Disease medication is not administered, it sends missed medication reminder alerts to the nurse. For fixed time medication, the reminder is every 3 minutes up to 10 minutes.
During the prospective phase, the research team will collect data from multiple sources such as the Watch Rx system, EPIC Hyperspace, and Case Report forms over a 6 month study period. The data will be calculated by using statistical analysis for the continuous variables and categorical variables identified from the collection of data. All study data will be imported into SAS software where data programming will be utilized to flag and generate queries on out-of-range data issues until they are resolved. All analysis will be performed using SAS version 9.4 (SAS Institute Inc. Cary, North Carolina, USA Data will be handled in a confidential manner to meet mandated IT Security standards and to prevent loss of privacy. All electronic files will be stored in an encrypted and password-protected database on a secure medical center server. Only co-investigators, advanced practice nurses, and the data coordinator who contact the subjects will have access to information linked to subject identifiers.
This study will improve timely administration of medications to PD patients. Patients enrolled in the study will have direct monitoring of their medication compliance and adherence. Patients participating in the registry will be gain information from the current research and possibly create a support group amongst themselves. This study will improve knowledge of Parkinson's disease amongst clinicians and better medication management of PD patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Retrospective Phase | Experimental | Device: Watch Rx systemPatients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program. |
| Prospective Phase-Watch Rx system | Experimental | Device: Watch Rx system, Other: Parkinson's Disease Inpatient Clinical Knowledge and Management ProgramPatients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system |
| Retrospective Phase - Clinicians | Experimental | Other: Parkinson's Disease Inpatient Clinical Knowledge and Management ProgramClinicians, 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. |
| Prospective Phase - Clinicians | Experimental | Other: Parkinson's Disease Inpatient Clinical Knowledge and Management ProgramClinicians, 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watch Rx systemThe 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 | Device | Prospective Phase-Watch Rx system, Retrospective Phase |
| Parkinson's Disease Inpatient Clinical Knowledge and Management ProgramParkinson'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 | Other | Prospective Phase - Clinicians, Prospective Phase-Watch Rx system, Retrospective Phase - Clinicians |
Primary outcome
Clinician's Parkinson's Disease Knowledge Assessment Survey Scores
Time frame: 6 months
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.
8 secondary outcomes
Number of PD Medications Administered on Time (15 Minute Window)
Time frame: within 15 minutes post PD medication administration time
Number of Patients With Contraindicated Medications Administered.
Time frame: 6 months
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Time frame: 6 Months
Length of Stay in Hospitalized Parkinson's Disease Patients.
Time frame: 6 months
Number of PD Medications Administered on Time (Within 15 Minute Window)
Time frame: 15 minutes post assigned medication administration time.
Number of PD Medication Errors After Using the WatchRX System
Time frame: 6 Months
Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System
Time frame: 6 months
Length of Stay With the WatchRx System
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azmi Hooman, MD principal investigator
Hackensack Meridian Health
Mohammed Quadri, MD, MBA principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watch Rx system and Parkinson's Disease Inpatient Clinical Knowledge and Management Program in people with Parkinson Disease, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician's Parkinson's Disease Knowledge Assessment Survey Scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.