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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04500106|
Recruitment Status : Active, not recruiting
First Posted : August 5, 2020
Last Update Posted : September 10, 2021
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|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|
|Actual Study Start Date :||April 22, 2021|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
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.
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500106
|Royal Brisbane and Women's Hospital /ID# 223138|
|Herston, Queensland, Australia, 4029|
|Kingston Centre /ID# 222563|
|Cheltenham, Victoria, Australia, 3192|
|The Royal Melbourne Hospital /ID# 223005|
|Parkville, Victoria, Australia, 3052|
|Soroka University Medical Center /ID# 222754|
|Beer Sheva, HaDarom, Israel, 8410101|
|Sheba Medical Center /ID# 222470|
|Ramat Gan, Tel-Aviv, Israel, 5239424|
|Kaplan Medical Center /ID# 222753|
|Rehovot, Israel, 7661041|
|Tel Aviv Medical Center /ID# 222471|
|Tel Aviv, Israel, 64239|
|Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934|
|Wroclaw, Dolnoslaskie, Poland, 50-369|
|Mazowiecki Szpital Brodnowski /ID# 222933|
|Warszawa, Mazowieckie, Poland, 03-242|
|COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932|
|Gdansk, Pomorskie, Poland, 80-462|
|Luzerner Kantonsspital /ID# 223038|
|Luzern 16, Luzern, Switzerland, 6000|
|Kantonsspital St. Gallen /ID# 227012|
|St. Gallen, Sankt Gallen, Switzerland, 9007|
|Universitätsspital Zürich /ID# 223035|
|Zürich, Zuerich, Switzerland, 8091|
|Study Director:||ABBVIE INC.||AbbVie|