Management of Patients Who Claim to be Electrosensitive | NCT06556901

Studies
Management of Patients Who Claim to be Electrosensitive

NCT06556901

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Aug 16, 2024Actual

Enrollment

1,400Actual

Phase

Not provided

Conditions

Electromagnetic Field

Interventions

retrospective study about reasons for consultations

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

Aug 2024

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

Jan 1, 2021Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Jun 4, 2021

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 16, 2024Actual

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

Aug 13, 2024

Last Update Posted Date

Aug 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses

Detailed Description

The Ministry of Health instructed the French society of medicine work (Dr Pougnet for the Brest CHRU) to coordinate the drafting of practical guides for the management of people claiming to have IEI-CEM (Intolerance Environmental Idiopathic in the Fields ElectroMagnetic) for care physicians primary (general practitioners). To meet this mission, it is necessary to know qualitatively the difficulties encountered by general practitioners during the management of these people.

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

1,400Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
retrospective study about reasons for consultations	Other	retrospective study about reasons for consultations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
principal	The main endpoint is to have taken care of a patient who claims to have electromagnetic sensibility.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: The inclusion criteria will be to be general practitioners, to have practiced between 01/01/2018 and 12/31/2018.

Exclusion Criteria:

be other practionners

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Population of general practitioners practicing in Brittany in 2018. Population assessed by the ODM between 3000 and 3200 liberal general practitioners

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32182484	Background	Vanderstraeten J, Verschaeve L. Biological effects of radiofrequency fields: Testing a paradigm shift in dosimetry. Environ Res. 2020 May;184:109387. doi: 10.1016/j.envres.2020.109387. Epub 2020 Mar 12.

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration