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

NCT ID: NCT04500106

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-10-14

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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Royal Brisbane and Women's Hospital /ID# 223138

Herston, Queensland, Australia

Kingston Centre /ID# 222563

Cheltenham, Victoria, Australia

The Royal Melbourne Hospital /ID# 223005

Parkville, Victoria, Australia

Soroka University Medical Center /ID# 222754

Beersheba, Southern District, Israel

The Chaim Sheba Medical Center /ID# 222470

Ramat Gan, Tel Aviv, Israel

Kaplan Medical Center /ID# 222753

Rehovot, , Israel

Tel Aviv Medical Center /ID# 222471

Tel Aviv, , Israel

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

Wroclaw, Lower Silesian Voivodeship, Poland

Mazowiecki Szpital Brodnowski /ID# 222933

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Luzerner Kantonsspital /ID# 223038

Lucerne, Canton of Lucerne, Switzerland

Kantonsspital St. Gallen /ID# 227012

Sankt Gallen, Canton of St. Gallen, Switzerland

Universitätsspital Zürich /ID# 223035

Zurich, Canton of Zurich, Switzerland

Countries

Australia; Israel; Poland; Switzerland

References

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.

Reference Type: DERIVED

PMID: 39224799 (View on PubMed)

Related Links

https://www.abbvieclinicaltrials.com/study/?id=P20-184&Latitude=&Longitude=&LocationName=#additional-resources-section

clinical study report synopsis

Other Identifiers

P20-184

Identifier Type: -

Identifier Source: org_study_id