NCT04500106

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

August 3, 2020

Last Update Submit

January 31, 2023

Conditions

Parkinson's Disease

Keywords

Levodopa-CarbidopaLCIGFACILITATE-CARE

Outcome Measures

Primary Outcomes (1)

  • 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).

    At Week 12

Secondary Outcomes (7)

  • Participant Satisfaction With ADS Nurse Support and Communication Access

    Through Week 12

  • Participant Satisfaction with the ADS Nurse Support and Communication Access

    At Week 12

  • Caregiver Satisfaction With ADS Nurse Support and Communication Access

    Baseline (Week 0) to Week 12

  • Caregiver Acceptance of ADS Nurse Support and Communication Access

    Through Week 12

  • Investigator Satisfaction With Nurse Support

    At Week 12

  • +2 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with advanced Parkinson's Disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Royal Brisbane and Women's Hospital /ID# 223138

Herston, Queensland, 4029, Australia

Location

Kingston Centre /ID# 222563

Cheltenham, Victoria, 3192, Australia

Location

The Royal Melbourne Hospital /ID# 223005

Parkville, Victoria, 3050, Australia

Location

Soroka University Medical Center /ID# 222754

Beersheba, Southern District, 8410101, Israel

Location

The Chaim Sheba Medical Center /ID# 222470

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Kaplan Medical Center /ID# 222753

Rehovot, 7661041, Israel

Location

Tel Aviv Medical Center /ID# 222471

Tel Aviv, 64239, Israel

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934

Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

Location

Mazowiecki Szpital Brodnowski /ID# 222933

Warsaw, Masovian Voivodeship, 03-242, Poland

Location

COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932

Gdansk, Pomeranian Voivodeship, 80-462, Poland

Location

Luzerner Kantonsspital /ID# 223038

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen /ID# 227012

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Universitätsspital Zürich /ID# 223035

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Gurevich T, Evans A, Hassin-Baer S, Kagi G, Koziorowski D, Roszmann A, Bergmann L, Parra Riaza JC, Sanchez-Solino O, Slawek J. Satisfaction with videoconferencing support for levodopa-carbidopa intestinal gel: An observational study. Digit Health. 2024 Aug 30;10:20552076241271847. doi: 10.1177/20552076241271847. eCollection 2024 Jan-Dec.

    PMID: 39224799DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 5, 2020

Study Start

April 22, 2021

Primary Completion

October 14, 2021

Study Completion

October 14, 2021

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

AU(3)IL(4)PL(3)CH(3)