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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)

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ClinicalTrials.gov Identifier: NCT04500106
Recruitment Status : Completed
First Posted : August 5, 2020
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Parkinson's Disease

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : October 14, 2021
Actual Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with advanced Parkinson's Disease
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

Information from the National Library of Medicine

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


Locations
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Australia, Queensland
Royal Brisbane and Women's Hospital /ID# 223138
Herston, Queensland, Australia, 4029
Australia, Victoria
Kingston Centre /ID# 222563
Cheltenham, Victoria, Australia, 3192
The Royal Melbourne Hospital /ID# 223005
Parkville, Victoria, Australia, 3050
Israel
Soroka University Medical Center /ID# 222754
Beer Sheva, HaDarom, Israel, 8410101
The Chaim Sheba Medical Center /ID# 222470
Ramat Gan, Tel-Aviv, Israel, 5265601
Kaplan Medical Center /ID# 222753
Rehovot, Israel, 7661041
Tel Aviv Medical Center /ID# 222471
Tel Aviv, Israel, 64239
Poland
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
Switzerland
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
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04500106    
Other Study ID Numbers: P20-184
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Levodopa-Carbidopa
LCIG
FACILITATE-CARE
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases