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

Study Overview
=================
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.

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

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Consulting with PARKINSUN as communication aid-tool
* Other: Consulting without PARKINSUN as communication aid-tool


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: consultation with Parkinsun<br> | Other: Consulting with PARKINSUN as communication aid-tool<br>* Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months<br>|
| Active Comparator: consultation as usual without Parkinsun<br> | Other: Consulting without PARKINSUN as communication aid-tool<br>* Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of the delta of G-MISS Questionnaire |  | at 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-MISS-Questionnaire at the end of each consultation (1 month, 4 months 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. | 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) | 
| Likert Scale |  | at 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health pathway, patient centered care, communication aid- tool, primary care, secondary care