Clinical trial NCT04500106: Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Levodopa-Carbidopa
LCIG
FACILITATE-CARE
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with advanced Parkinson's Disease

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.


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

Primary outcomes:
measure: Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access
timeFrame: At Week 12
Secondary outcomes:
measure: Participant Satisfaction With ADS Nurse Support and Communication Access
timeFrame: Through Week 12
measure: Participant Satisfaction with the ADS Nurse Support and Communication Access
timeFrame: At Week 12
measure: Caregiver Satisfaction With ADS Nurse Support and Communication Access
timeFrame: Baseline (Week 0) to Week 12
measure: Caregiver Acceptance of ADS Nurse Support and Communication Access
timeFrame: Through Week 12
measure: Investigator Satisfaction With Nurse Support
timeFrame: At Week 12
measure: Participant Satisfaction With Video Functionality of the Device
timeFrame: Through Week 12
measure: Change of Caregiver Burden
timeFrame: Baseline (Week 0) to Week 12
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 223138
state: Queensland
city: Cheltenham
country: Australia
facility: Kingston Centre /ID# 222563
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 223005
state: Victoria
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center /ID# 222754
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 222470
state: Tel-Aviv
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 222753
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center /ID# 222471
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Mazowiecki Szpital Brodnowski /ID# 222933
state: Mazowieckie
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932
state: Pomorskie
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital /ID# 223038
state: Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 227012
state: Sankt Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich /ID# 223035
state: Zuerich
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: