Integrated Parkinson Care Networks: Assessment of Economi... | NCT04485468

Studies
Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers

NCT04485468

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2021Actual

Primary Completion Date

Jul 2, 2021Actual

Completion Date

Jul 2, 2021Actual

First Submitted Date

Jul 21, 2020

First Submission Date that Met QC Criteria

Jul 21, 2020

First Posted Date

Jul 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.

It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.

Detailed Description

According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients

The coordination of the care pathway for patients with Parkinson disease has been improved since the implementation on the national territory of 7 interregional coordination centers and 25 regional expert centers in 2012.

Health insurance reimburses 100% of direct medical and non-medical care as soon as patients are registered in Long-Term Condition n°16. However, we currently have little information about care that is not recognized for financial coverage by health insurance.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's disease patients		Parkinson's disease patients and over 18 years old	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the economic barriers to an optimal care path	It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.	Day 0

Secondary Outcomes

Measure	Description	Time Frame
Identify and quantify the cost of the care pathway for patients with Parkinson's disease	it is the quantification of the number of resources consumed and identification of the unit costs for each type of resources consumed.	Day 0
identify socio-economic determinants

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Parkinson's disease of any stage of severity
Patients over 18 years of age
Patients living at home
Patient consultant at the expert center Parkinson's at Toulouse University Hospital

Exclusion Criteria:

Pregnant and lactating woman
Patient under guardianship, curatorship or safeguard of justice
Person who does not understand French to be able to answer the questionnaire
Patient who participated or participated in the iCare PD project

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Parkinson's disease patients and over 18 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Rascol	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Toulouse		Toulouse		31059	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided