Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel
- Conditions
- Parkinson's Disease
- Registration Number
- NCT04500106
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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).
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.
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).
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).
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).
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).
Trial Locations
- Locations (13)
The Chaim Sheba Medical Center /ID# 222470
🇮🇱Ramat Gan, Tel-Aviv, Israel
Kaplan Medical Center /ID# 222753
🇮🇱Rehovot, Israel
Kingston Centre /ID# 222563
🇦🇺Cheltenham, Victoria, Australia
Soroka University Medical Center /ID# 222754
🇮🇱Beer Sheva, HaDarom, Israel
Luzerner Kantonsspital /ID# 223038
🇨ðŸ‡Luzern 16, Luzern, Switzerland
The Royal Melbourne Hospital /ID# 223005
🇦🇺Parkville, Victoria, Australia
Mazowiecki Szpital Brodnowski /ID# 222933
🇵🇱Warszawa, Mazowieckie, Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932
🇵🇱Gdansk, Pomorskie, Poland
Kantonsspital St. Gallen /ID# 227012
🇨ðŸ‡St. Gallen, Sankt Gallen, Switzerland
Universitätsspital Zürich /ID# 223035
🇨ðŸ‡Zürich, Zuerich, Switzerland
Royal Brisbane and Women's Hospital /ID# 223138
🇦🇺Herston, Queensland, Australia
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934
🇵🇱Wroclaw, Dolnoslaskie, Poland
Tel Aviv Medical Center /ID# 222471
🇮🇱Tel Aviv, Israel