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Completed

NCT Number: 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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brisbane and Women's Hospital /ID# 223138, Herston, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Observational Study to Investigate the Feasibility and Patient/Caregiver/Investigator Satisfaction of Video-assisted Telenursing Use in Nurse Support Programs With LCIG

Acronym: FACILITATECARE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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