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

Not Applicable

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Other: Consulting with PARKINSUN as communication aid-tool; Other: Consulting without PARKINSUN as communication aid-tool

• Registration Number: NCT04179695
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Study Start: 2020-07-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
consultation with Parkinsun	Consulting with PARKINSUN as communication aid-tool	-
consultation as usual without Parkinsun	Consulting without PARKINSUN as communication aid-tool	-

Primary Outcome Measures

Name	Time	Method
variation of the delta of G-MISS Questionnaire	at 7 months

Secondary Outcome Measures

Name	Time	Method
Likert Scale	at the end of each consultation (1 month and 7 months)
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)
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)	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)
Interpersonal Reactivity Index (IRI)	at the end of each consultation (1 month and 7 months)

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France