Clinical trial NCT04179695: Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care
Official title: Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Health pathway
patient centered care
communication aid- tool
primary care
secondary care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Expert center of Parkinson's Disease (CHU Lille)
name: College of teaching general practitioners (CEMG Lille)
name: Regional Health Agency (ARS)
name: UCB Pharma
name: Orkyn'
First posted: 2019-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: variation of the delta of G-MISS Questionnaire
timeFrame: at 7 months
Secondary outcomes:
measure: G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)
timeFrame: at the end of each consultation (1 month and 7 months)
measure: Global score of PARKINSUN
timeFrame: at the end of each consultation ((1 month and 7 months)
measure: Individuals scores of PARKINSUN
timeFrame: at the end of each consultation ((1 month and 7 months)
measure: MDS-UPDRS scores
timeFrame: at the end of each consultation ((1 month and 7 months)
measure: PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)
timeFrame: at the end of each consultation ((1 month and 7 months)
measure: Likert Scale
timeFrame: at the end of each consultation (1 month and 7 months)
measure: Interpersonal Reactivity Index (IRI)
timeFrame: at the end of each consultation (1 month and 7 months)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: David Devos
role: PRINCIPAL_INVESTIGATOR
References: