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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
Date last updated
2/02/2023

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
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Participant Satisfaction With ADS Nurse Support and Communication Access
Timepoint [1] 0 0
Through Week 12
Secondary outcome [2] 0 0
Participant Satisfaction with the ADS Nurse Support and Communication Access
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Caregiver Satisfaction With ADS Nurse Support and Communication Access
Timepoint [3] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [4] 0 0
Caregiver Acceptance of ADS Nurse Support and Communication Access
Timepoint [4] 0 0
Through Week 12
Secondary outcome [5] 0 0
Investigator Satisfaction With Nurse Support
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Participant Satisfaction With Video Functionality of the Device
Timepoint [6] 0 0
Through Week 12
Secondary outcome [7] 0 0
Change of Caregiver Burden
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2021
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital /ID# 223138 - Herston
Recruitment hospital [2] 0 0
Kingston Centre /ID# 222563 - Cheltenham
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital /ID# 223005 - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3192 - Cheltenham
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
HaDarom
Country [2] 0 0
Israel
State/province [2] 0 0
Tel-Aviv
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
Poland
State/province [5] 0 0
Dolnoslaskie
Country [6] 0 0
Poland
State/province [6] 0 0
Mazowieckie
Country [7] 0 0
Poland
State/province [7] 0 0
Pomorskie
Country [8] 0 0
Switzerland
State/province [8] 0 0
Luzern
Country [9] 0 0
Switzerland
State/province [9] 0 0
Sankt Gallen
Country [10] 0 0
Switzerland
State/province [10] 0 0
Zuerich

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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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