Parkinson's DiseaseFACILITATECARENCT04500106
Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel
An observational study of Parkinson's Disease, run by AbbVie at 13 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 41 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 22 Apr 2021to 14 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with advanced Parkinson's Disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Israel4 sites
Soroka University Medical Center /ID# 222754
Beersheba, Southern District, 8410101
The Chaim Sheba Medical Center /ID# 222470
Ramat Gan, Tel Aviv, 5265601
Kaplan Medical Center /ID# 222753
Rehovot, 7661041
Tel Aviv Medical Center /ID# 222471
Tel Aviv, 64239
Australia3 sites
Kingston Centre /ID# 222563
Cheltenham, Victoria, 3192
Royal Brisbane and Women's Hospital /ID# 223138
Herston, Queensland, 4029
The Royal Melbourne Hospital /ID# 223005
Parkville, Victoria, 3050
Poland3 sites
COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932
Gdansk, Pomeranian Voivodeship, 80-462
Mazowiecki Szpital Brodnowski /ID# 222933
Warsaw, Masovian Voivodeship, 03-242
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934
Wroclaw, Lower Silesian Voivodeship, 50-369
Switzerland3 sites
Luzerner Kantonsspital /ID# 223038
Lucerne, Canton of Lucerne, 6000
Kantonsspital St. Gallen /ID# 227012
Sankt Gallen, Canton of St. Gallen, 9007
Universitätsspital Zürich /ID# 223035
Zurich, Canton of Zurich, 8091
About this study
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
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.
Read more
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
- Keywords
- Levodopa-Carbidopa, LCIG, FACILITATE-CARE
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At Week 12
Secondary outcomes (7)
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).
Measured: Through Week 12
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).
Measured: At Week 12
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).
Measured: Baseline (Week 0) to Week 12
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).
Measured: Through Week 12
Investigator Satisfaction With Nurse Support
Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).
Measured: At Week 12
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).
Measured: Through Week 12
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.
Measured: Baseline (Week 0) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start22 Apr 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500106
- Sponsor's protocol ID
- P20-184
- Acronym
- FACILITATECARE
- Status last verified
- Jan 2023
- First submitted
- 3 Aug 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39224799
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04500106
- Acronym / sponsor ID
- FACILITATECARE / P20-184
- Conditions
- Parkinson's Disease
- Keywords
- Levodopa-Carbidopa, LCIG, FACILITATE-CARE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with advanced Parkinson's Disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
Participant Satisfaction With ADS Nurse Support and Communication Access
Time frame: Through Week 12
Participant Satisfaction with the ADS Nurse Support and Communication Access
Time frame: At Week 12
Caregiver Satisfaction With ADS Nurse Support and Communication Access
Time frame: Baseline (Week 0) to Week 12
Caregiver Acceptance of ADS Nurse Support and Communication Access
Time frame: Through Week 12
Investigator Satisfaction With Nurse Support
Time frame: At Week 12
Participant Satisfaction With Video Functionality of the Device
Time frame: Through Week 12
Change of Caregiver Burden
Time frame: Baseline (Week 0) to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 39224799Gurevich 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by AbbVie at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Israel, Australia, Poland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.