Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care (PARKINSUN)

Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN

PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Consulting with PARKINSUN as communication aid-tool; Other: Consulting without PARKINSUN as communication aid-tool

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Devos, MD,PhD; Phone Number: +33 03 20 44 54 49; Email: david.devos@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hôpital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult men and women with all stages of PD
• Without severe chronic neurological or mental or psychiatric pathology
• Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA > 22)
• able to come (alone or accompanied) to consultation
• Affiliate or beneficiary of a social security scheme
• Subject having signed informed consent
• Patient willing to comply with all procedures of the study and its duration

Exclusion Criteria:

• Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
• Subject under tutelage or curtailer.
• Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: consultation with Parkinsun	Other: Consulting with PARKINSUN as communication aid-tool; Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months
Active Comparator: consultation as usual without Parkinsun	Other: Consulting without PARKINSUN as communication aid-tool; Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
variation of the delta of G-MISS Questionnaire	at 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)	Patient's satisfaction will be assessed by the G-MISS-Questionnaire. The G-MISS questionnaire is a standardized and validated tool in French. This questionnaire is taken from the American MISS-21 questionnaire, already used in neurologists to measure the satisfaction of patients with PD, after consultation It is easy to use with an average filling time of 6 minutes.	at the end of each consultation (1 month and 7 months)
Global score of PARKINSUN		at the end of each consultation ((1 month and 7 months)
Individuals scores of PARKINSUN		at the end of each consultation ((1 month and 7 months)
MDS-UPDRS scores		at the end of each consultation ((1 month and 7 months)
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)		at the end of each consultation ((1 month and 7 months)
Likert Scale		at the end of each consultation (1 month and 7 months)
Interpersonal Reactivity Index (IRI)		at the end of each consultation (1 month and 7 months)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: UCB Pharma; Orkyn'; Expert center of Parkinson's Disease (CHU Lille); College of teaching general practitioners (CEMG Lille); Regional Health Agency (ARS)
• Investigators: Principal Investigator: David Devos, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: primary care; patient centered care; Health pathway; communication aid- tool; secondary care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2018_74; 2019-A01008-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No