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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04179695

Collaborator

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

120

Enrollment

Location

Arms

31.3

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Other: Consulting with PARKINSUN as communication aid-tool Other: Consulting without PARKINSUN as communication aid-tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 21, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: consultation with Parkinsun

Other: Consulting with PARKINSUN as communication aid-tool

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

Active Comparator: consultation as usual without Parkinsun

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

Outcome Measures

Primary Outcome Measures

variation of the delta of G-MISS Questionnaire [at 7 months]

Secondary Outcome Measures

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)]
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.
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.