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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04500106




Registration number
NCT04500106
Ethics application status
Date submitted
3/08/2020
Date registered
5/08/2020
Date last updated
21/12/2020

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
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
Secondary ID [1] 0 0
P20-184
Universal Trial Number (UTN)
Trial acronym
FACILITATECARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access - 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).
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Participant Satisfaction With ADS Nurse Support and Communication Access - 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).
Timepoint [1] 0 0
Through Week 12
Secondary outcome [2] 0 0
Participant Satisfaction with the ADS Nurse Support and Communication Access - Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No).
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Caregiver Satisfaction With ADS Nurse Support and Communication Access - 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).
Timepoint [3] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [4] 0 0
Caregiver Acceptance of ADS Nurse Support and Communication Access - 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).
Timepoint [4] 0 0
Through Week 12
Secondary outcome [5] 0 0
Investigator Satisfaction With Nurse Support - Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Participant Satisfaction With Video Functionality of the Device - 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).
Timepoint [6] 0 0
Through Week 12
Secondary outcome [7] 0 0
Change of Caregiver Burden - 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.
Timepoint [7] 0 0
Baseline (Week 0) to Week 12

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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital /ID# 223138 - Herston
Recruitment hospital [2] 0 0
Launceston General Hospital /ID# 222566 - Launceston
Recruitment hospital [3] 0 0
Kingston Centre /ID# 222563 - Cheltenham
Recruitment hospital [4] 0 0
Royal Melbourne Hospital /ID# 223005 - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
7250 - Launceston
Recruitment postcode(s) [3] 0 0
3192 - Cheltenham
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Be'er Sheva
Country [2] 0 0
Israel
State/province [2] 0 0
Ramat Gan
Country [3] 0 0
Israel
State/province [3] 0 0
Rehovot
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Aviv
Country [5] 0 0
Switzerland
State/province [5] 0 0
Zuerich
Country [6] 0 0
Switzerland
State/province [6] 0 0
Luzern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04500106
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04500106