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

November 16, 2021 updated by: AbbVie

An Observational Study to Investigate the Feasibility and Patient/Caregiver/Investigator Satisfaction of Video-assisted Telenursing Use in Nurse Support Programs With LCIG

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants with advanced Parkinson's Disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access
Time Frame: 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).
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction With ADS Nurse Support and Communication Access
Time Frame: 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).
Through Week 12
Participant Satisfaction with the ADS Nurse Support and Communication Access
Time Frame: 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).
At Week 12
Caregiver Satisfaction With ADS Nurse Support and Communication Access
Time Frame: 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).
Baseline (Week 0) to Week 12
Caregiver Acceptance of ADS Nurse Support and Communication Access
Time Frame: 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).
Through Week 12
Investigator Satisfaction With Nurse Support
Time Frame: At Week 12
Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).
At Week 12
Participant Satisfaction With Video Functionality of the Device
Time Frame: 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).
Through Week 12
Change of Caregiver Burden
Time Frame: 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.
Baseline (Week 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Actual)

October 14, 2021

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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