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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04500106
Registration number
NCT04500106
Ethics application status
Date submitted
3/08/2020
Date registered
5/08/2020
Titles & IDs
Public title
Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel
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Scientific title
An Observational Study to Investigate the Feasibility and Patient/Caregiver/Investigator Satisfaction of Video-assisted Telenursing Use in Nurse Support Programs With LCIG
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Secondary ID [1]
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P20-184
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Universal Trial Number (UTN)
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Trial acronym
FACILITATECARE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
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Condition category
Condition code
Neurological
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Parkinson's disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants With Nurse Support, Using Video Devices - Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, using video devices.
Participants With Nurse Support, Not Using Video Devices - Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, not using video devices.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access
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Assessment method [1]
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Participant acceptance is measured by the participant satisfaction with the AbbVie Duodopa Specialist (ADS) nurse support and communication access (Visual Analog Sore from 1 to 10).
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Timepoint [1]
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At Week 12
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Secondary outcome [1]
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Participant Satisfaction With ADS Nurse Support and Communication Access
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Assessment method [1]
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Participant Satisfaction is defined as participant satisfaction with the ADS nurse support and communication access at Week 4 (Visual Analog Scale \[VAS\] scoring from 1 to 10) and at Week 12 (VAS scoring from 8 to 10).
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Timepoint [1]
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Through Week 12
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Secondary outcome [2]
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Participant Satisfaction with the ADS Nurse Support and Communication Access
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Assessment method [2]
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Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No).
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Timepoint [2]
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At Week 12
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Secondary outcome [3]
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Caregiver Satisfaction With ADS Nurse Support and Communication Access
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Assessment method [3]
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Caregiver satisfaction is measured as the satisfaction of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).
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Timepoint [3]
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Baseline (Week 0) to Week 12
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Secondary outcome [4]
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Caregiver Acceptance of ADS Nurse Support and Communication Access
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Assessment method [4]
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Caregiver acceptance is measured as the acceptance of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).
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Timepoint [4]
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Through Week 12
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Secondary outcome [5]
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Investigator Satisfaction With Nurse Support
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Assessment method [5]
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Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).
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Timepoint [5]
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At Week 12
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Secondary outcome [6]
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Participant Satisfaction With Video Functionality of the Device
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Assessment method [6]
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Participant satisfaction is defined as the measure of satisfaction of participant with the video functionality of the device specifically at weeks 4 and 12 (VAS from 1 to 10).
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Timepoint [6]
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Through Week 12
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Secondary outcome [7]
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Change of Caregiver Burden
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Assessment method [7]
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Change of caregiver burden will be measured by the Modified Caregiver Strain Index (MCSI). MCSI is a questionnaire comprising of 13 questions around major domains, to be filled by caregivers. The higher the score, the higher the level of caregiver strain. Scoring ranges from 0 to 26, with 0 indicating no strain and 26 indicating extreme strain.
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Timepoint [7]
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Baseline (Week 0) to Week 12
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Eligibility
Key inclusion criteria
* Eligible for Levodopa-Carbidopa Intestinal Gel (LCIG) therapy in accordance with the approved local LCIG label in the participating country
* Formerly LCIG-naive participants who have completed an in-hospital titration, have a Percutaneous Endoscopic transGastric Jejunostomy (PEG-J) placed and are discharged from hospital
* Decision to treat with LCIG made by the investigator prior to any decision to approach the participant to participate in this study
* Owns a telecommunication device equipped for videoconferencing (smart phone, tablet, laptop)
* Willing and able (based on investigator's judgment) to handle the video functionality of the device
* Caregiver willing to provide written informed consent
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any condition included in the contraindications section of the approved local LCIG label in the participating country
* Lack of caregiver support
* Participation in a concurrent interventional clinical trial
* Lack of motivation or insufficient language skills to complete the study questionnaires
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/10/2021
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital /ID# 223138 - Herston
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Recruitment hospital [2]
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Kingston Centre /ID# 222563 - Cheltenham
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Recruitment hospital [3]
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The Royal Melbourne Hospital /ID# 223005 - Parkville
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3192 - Cheltenham
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
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HaDarom
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Country [2]
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Israel
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State/province [2]
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Tel-Aviv
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Country [3]
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Israel
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State/province [3]
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Rehovot
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Country [4]
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Israel
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State/province [4]
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Tel Aviv
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Country [5]
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Poland
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State/province [5]
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Dolnoslaskie
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Country [6]
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Poland
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State/province [6]
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Mazowieckie
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Country [7]
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Poland
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State/province [7]
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Pomorskie
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Country [8]
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Switzerland
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State/province [8]
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Luzern
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Country [9]
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Switzerland
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State/province [9]
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Sankt Gallen
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Country [10]
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Switzerland
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State/province [10]
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Zuerich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how feasible and how satisfied participants/caregivers/investigators are with video-assisted telenursing use in nurse support programs with LCIG. LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD will be enrolled in the study at approximately 10 sites across the world. The study has 2 groups. In one group, around 25 participants will receive nurse support using video devices. In the second group, around 25 participants will receive nurse support without using video devices. All participants will attend a baseline visit and follow up visits at Week 4 and Week 12. The planned observation period will be 12 weeks. Participants who are prescribed LCIG by their physicians will have three study related visits. Participants, caregivers, and investigators will be asked to complete questionnaires for the study.
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Trial website
https://clinicaltrials.gov/study/NCT04500106
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04500106