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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

Tracking Information
First Submitted Date August 3, 2020
First Posted Date August 5, 2020
Last Update Posted Date November 17, 2021
Actual Study Start Date April 22, 2021
Actual Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2020)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2020)
  • 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.
Original Secondary Outcome Measures
 (submitted: August 3, 2020)
  • 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 Scoring 8 to 10 on a VAS 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult participants with advanced Parkinson's Disease
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2021)
41
Original Estimated Enrollment
 (submitted: August 3, 2020)
50
Actual Study Completion Date October 14, 2021
Actual Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Israel,   Poland,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04500106
Other Study ID Numbers P20-184
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date November 2021