Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel

Study Identifier
P20-184
CT.gov Identifier
NCT04500106
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 85 Years
    Inclusion and Exclusion Criteria
    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
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Royal Brisbane and Women's Hospital /ID# 223138
    Herston, Queensland, Australia, 4029
    Status
    Not applicable
    Location
    Kingston Centre /ID# 222563
    Cheltenham, Victoria, Australia, 3192
    Status
    Not applicable
    Location
    The Royal Melbourne Hospital /ID# 223005
    Parkville, Victoria, Australia, 3050
    Status
    Not applicable
    Location
    Soroka University Medical Center /ID# 222754
    Beersheba, Southern District, Israel, 8410101
    Status
    Not applicable
    Location
    The Chaim Sheba Medical Center /ID# 222470
    Ramat Gan, Tel Aviv, Israel, 5265601
    Status
    Not applicable
    Location
    Kaplan Medical Center /ID# 222753
    Rehovot, Israel, 7661041
    Status
    Not applicable
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