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Recruiting

NCT Number: NCT04179695

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

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Consulting with PARKINSUN as communication aid-tool

Other

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

Consulting without PARKINSUN as communication aid-tool

Other

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

Primary outcomes

  1. variation of the delta of G-MISS Questionnaire

    Time frame: at 7 months

Secondary outcomes

  1. G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)

    Time frame: 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.

  2. Global score of PARKINSUN

    Time frame: at the end of each consultation ((1 month and 7 months)

  3. Individuals scores of PARKINSUN

    Time frame: at the end of each consultation ((1 month and 7 months)

  4. MDS-UPDRS scores

    Time frame: at the end of each consultation ((1 month and 7 months)

  5. PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)

    Time frame: at the end of each consultation ((1 month and 7 months)

  6. Likert Scale

    Time frame: at the end of each consultation (1 month and 7 months)

  7. Interpersonal Reactivity Index (IRI)

    Time frame: at the end of each consultation (1 month and 7 months)

Study contacts

Contact information is provided by the study sponsor or research team.

David Devos, MD,PhD

CONTACT

[email protected]

03 20 44 54 49 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • College of teaching general practitioners (CEMG Lille)
  • Expert center of Parkinson's Disease (CHU Lille)
  • Orkyn'
  • Regional Health Agency (ARS)
  • UCB Pharma

Registry information

Official study title

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

Acronym: PARKINSUN

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2019
Registry last updated
Dec 23, 2025

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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