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

Parkinson's Disease Clinical Trial

— PARKINSUN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179695
• Other study ID #: 2018_74
• Secondary ID: 2019-A01008-49
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: March 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: David Devos, MD,PhD
• Phone: 03 20 44 54 49
• Email: david.devos[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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
• Consulting without PARKINSUN as communication aid-tool
Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Lille	College of teaching general practitioners (CEMG Lille), Expert center of Parkinson's Disease (CHU Lille), Orkyn', Regional Health Agency (ARS), UCB Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of the delta of G-MISS Questionnaire		at 7 months
Secondary	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)
Secondary	Global score of PARKINSUN		at the end of each consultation ((1 month and 7 months)
Secondary	Individuals scores of PARKINSUN		at the end of each consultation ((1 month and 7 months)
Secondary	MDS-UPDRS scores		at the end of each consultation ((1 month and 7 months)
Secondary	PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)		at the end of each consultation ((1 month and 7 months)
Secondary	Likert Scale		at the end of each consultation (1 month and 7 months)
Secondary	Interpersonal Reactivity Index (IRI)		at the end of each consultation (1 month and 7 months)