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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04179695
Acronym
PARKINSUN
Enrollment
120
Registered
2019-11-27
Start date
2020-07-21
Completion date
2026-12-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Health pathway, patient centered care, communication aid- tool, primary care, secondary care

Brief summary

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.

Interventions

OTHERConsulting with PARKINSUN as communication aid-tool

Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months

OTHERConsulting without PARKINSUN as communication aid-tool

Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months

Sponsors

Expert center of Parkinson's Disease (CHU Lille)
CollaboratorUNKNOWN
College of teaching general practitioners (CEMG Lille)
CollaboratorUNKNOWN
Regional Health Agency (ARS)
CollaboratorUNKNOWN
UCB Pharma
CollaboratorINDUSTRY
Orkyn'
CollaboratorINDUSTRY
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
variation of the delta of G-MISS Questionnaireat 7 months

Secondary

MeasureTime frameDescription
Global score of PARKINSUNat the end of each consultation ((1 month and 7 months)
Individuals scores of PARKINSUNat the end of each consultation ((1 month and 7 months)
MDS-UPDRS scoresat the end of each consultation ((1 month and 7 months)
G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)at the end of each consultation (1 month 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.
Likert Scaleat 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)
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)at the end of each consultation ((1 month and 7 months)

Countries

France

Contacts

Primary ContactDavid Devos, MD,PhD
david.devos@chru-lille.fr03 20 44 54 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026