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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT04500106
Collaborator
(none)
41
Enrollment
13
Locations
5.7
Actual Duration (Months)
3.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    41 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study to Investigate the Feasibility and Patient/Caregiver/Investigator Satisfaction of Video-assisted Telenursing Use in Nurse Support Programs With LCIG
    Actual Study Start Date :
    Apr 22, 2021
    Actual Primary Completion Date :
    Oct 14, 2021
    Actual Study Completion Date :
    Oct 14, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access [At Week 12]

      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).

    Secondary Outcome Measures

    1. Participant Satisfaction With ADS Nurse Support and Communication Access [Through Week 12]

      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).

    2. Participant Satisfaction with the ADS Nurse Support and Communication Access [At Week 12]

      Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No).

    3. Caregiver Satisfaction With ADS Nurse Support and Communication Access [Baseline (Week 0) to Week 12]

      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).

    4. Caregiver Acceptance of ADS Nurse Support and Communication Access [Through Week 12]

      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).

    5. Investigator Satisfaction With Nurse Support [At Week 12]

      Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).

    6. Participant Satisfaction With Video Functionality of the Device [Through Week 12]

      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).

    7. Change of Caregiver Burden [Baseline (Week 0) to Week 12]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Brisbane and Women's Hospital /ID# 223138 Herston Queensland Australia 4029
    2 Kingston Centre /ID# 222563 Cheltenham Victoria Australia 3192
    3 The Royal Melbourne Hospital /ID# 223005 Parkville Victoria Australia 3050
    4 Soroka University Medical Center /ID# 222754 Beer Sheva HaDarom Israel 8410101
    5 The Chaim Sheba Medical Center /ID# 222470 Ramat Gan Tel-Aviv Israel 5265601
    6 Kaplan Medical Center /ID# 222753 Rehovot Israel 7661041
    7 Tel Aviv Medical Center /ID# 222471 Tel Aviv Israel 64239
    8 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934 Wroclaw Dolnoslaskie Poland 50-369
    9 Mazowiecki Szpital Brodnowski /ID# 222933 Warszawa Mazowieckie Poland 03-242
    10 COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932 Gdansk Pomorskie Poland 80-462
    11 Luzerner Kantonsspital /ID# 223038 Luzern 16 Luzern Switzerland 6000
    12 Kantonsspital St. Gallen /ID# 227012 St. Gallen Sankt Gallen Switzerland 9007
    13 Universitätsspital Zürich /ID# 223035 Zürich Zuerich Switzerland 8091

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04500106
    Other Study ID Numbers:
    • P20-184
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Levodopa-Carbidopa
    LCIG
    FACILITATE-CARE
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Nov 17, 2021