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

Parkinson's Disease Clinical Trial

— FACILITATECARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500106
• Other study ID #: P20-184
• Status: Completed
• Start date: April 22, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Australia	Kingston Centre /ID# 222563	Cheltenham	Victoria
Australia	Royal Brisbane and Women's Hospital /ID# 223138	Herston	Queensland
Australia	The Royal Melbourne Hospital /ID# 223005	Parkville	Victoria
Israel	Soroka University Medical Center /ID# 222754	Beer Sheva	HaDarom
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
Poland	COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932	Gdansk	Pomorskie
Poland	Mazowiecki Szpital Brodnowski /ID# 222933	Warszawa	Mazowieckie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934	Wroclaw	Dolnoslaskie
Switzerland	Luzerner Kantonsspital /ID# 223038	Luzern 16	Luzern
Switzerland	Kantonsspital St. Gallen /ID# 227012	St. Gallen	Sankt Gallen
Switzerland	Universitätsspital Zürich /ID# 223035	Zürich	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Australia,  Israel,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant Satisfaction With ADS Nurse Support and Communication Access	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
Secondary	Participant Satisfaction with the ADS Nurse Support and Communication Access	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
Secondary	Caregiver Satisfaction With ADS Nurse Support and Communication Access	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
Secondary	Caregiver Acceptance of ADS Nurse Support and Communication Access	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
Secondary	Investigator Satisfaction With Nurse Support	Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).	At Week 12
Secondary	Participant Satisfaction With Video Functionality of the Device	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
Secondary	Change of Caregiver Burden	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

External Links

•   clinical study report synopsis