NCT04179695

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2020Dec 2026

First Submitted

Initial submission to the registry

November 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

6.4 years

First QC Date

November 25, 2019

Last Update Submit

December 16, 2025

Conditions

Parkinson's Disease

Keywords

Health pathwaypatient centered carecommunication aid- toolprimary caresecondary care

Outcome Measures

Primary Outcomes (1)

  • variation of the delta of G-MISS Questionnaire

    at 7 months

Secondary Outcomes (7)

  • 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)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

consultation with Parkinsun

EXPERIMENTAL
Other: Consulting with PARKINSUN as communication aid-tool

consultation as usual without Parkinsun

ACTIVE COMPARATOR
Other: Consulting without PARKINSUN as communication aid-tool

Interventions

Consulting with PARKINSUN as communication aid-toolOTHER

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

consultation with Parkinsun
Consulting without PARKINSUN as communication aid-toolOTHER

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

consultation as usual without Parkinsun

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • David Devos

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Devos, MD,PhD

CONTACT

03 20 44 54 49david.devos@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 27, 2019

Study Start

July 21, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)