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

NCT ID: NCT04179695

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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consultation with Parkinsun

Group Type EXPERIMENTAL

Consulting with PARKINSUN as communication aid-tool

Intervention Type OTHER

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

consultation as usual without Parkinsun

Group Type ACTIVE_COMPARATOR

Consulting without PARKINSUN as communication aid-tool

Intervention Type OTHER

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

Interventions

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Consulting with PARKINSUN as communication aid-tool

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Expert center of Parkinson's Disease (CHU Lille)

UNKNOWN

Sponsor Role collaborator

College of teaching general practitioners (CEMG Lille)

UNKNOWN

Sponsor Role collaborator

Regional Health Agency (ARS)

UNKNOWN

Sponsor Role collaborator

UCB Pharma

INDUSTRY

Sponsor Role collaborator

Orkyn'

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Devos

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hopital Roger Salengro, CHU Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David Devos, MD,PhD

Role: CONTACT

Phone: 03 20 44 54 49

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2019-A01008-49

Identifier Type: OTHER

Identifier Source: secondary_id

2018_74

Identifier Type: -

Identifier Source: org_study_id