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

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consulting with PARKINSUN as communication aid-tool
Consulting without PARKINSUN as communication aid-tool
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson's Disease focused on measuring Health pathway, patient centered care, communication aid- tool, primary care, secondary care

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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 > 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.

Sites / Locations

  • Hopital Roger Salengro, CHU LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

consultation with Parkinsun

consultation as usual without Parkinsun

Arm Description

Outcomes

Primary Outcome Measures

variation of the delta of G-MISS Questionnaire

Secondary Outcome Measures

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.
Global score of PARKINSUN
Individuals scores of PARKINSUN
MDS-UPDRS scores
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)
Likert Scale
Interpersonal Reactivity Index (IRI)

Full Information

First Posted
November 25, 2019
Last Updated
November 4, 2022
Sponsor
University Hospital, Lille
Collaborators
Expert center of Parkinson's Disease (CHU Lille), College of teaching general practitioners (CEMG Lille), Regional Health Agency (ARS), UCB Pharma, Orkyn'
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1. Study Identification

Unique Protocol Identification Number
NCT04179695
Brief Title
Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care
Acronym
PARKINSUN
Official Title
Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Expert center of Parkinson's Disease (CHU Lille), College of teaching general practitioners (CEMG Lille), Regional Health Agency (ARS), UCB Pharma, Orkyn'

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Health pathway, patient centered care, communication aid- tool, primary care, secondary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
consultation with Parkinsun
Arm Type
Experimental
Arm Title
consultation as usual without Parkinsun
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Consulting with PARKINSUN as communication aid-tool
Intervention Description
Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months
Intervention Type
Other
Intervention Name(s)
Consulting without PARKINSUN as communication aid-tool
Intervention Description
Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months
Primary Outcome Measure Information:
Title
variation of the delta of G-MISS Questionnaire
Time Frame
at 7 months
Secondary Outcome Measure Information:
Title
G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)
Description
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.
Time Frame
at the end of each consultation (1 month and 7 months)
Title
Global score of PARKINSUN
Time Frame
at the end of each consultation ((1 month and 7 months)
Title
Individuals scores of PARKINSUN
Time Frame
at the end of each consultation ((1 month and 7 months)
Title
MDS-UPDRS scores
Time Frame
at the end of each consultation ((1 month and 7 months)
Title
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)
Time Frame
at the end of each consultation ((1 month and 7 months)
Title
Likert Scale
Time Frame
at the end of each consultation (1 month and 7 months)
Title
Interpersonal Reactivity Index (IRI)
Time Frame
at the end of each consultation (1 month and 7 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Devos, MD,PhD
Phone
03 20 44 54 49
Ext
+33
Email
david.devos@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Devos
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Roger Salengro, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

Learn more about this trial

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

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