Alternative Care in Patients With Auto-Immune Diseases | NCT04094259

Studies
Alternative Care in Patients With Auto-Immune Diseases

NCT04094259

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Mar 27, 2026Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Auto-Immune Diseases

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

Aug 2022

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

Sep 9, 2019Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Sep 16, 2019

First Submission Date that Met QC Criteria

Sep 17, 2019

First Posted Date

Sep 18, 2019Actual

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

Mar 24, 2026

Last Update Posted Date

Mar 27, 2026Actual

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

Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with in the department of Internal Medicine A

Detailed Description

Patients followed in Internal Medicine department bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with autoimmune diseases in the department of Internal Medicine .

At all times alternative medicine has existed. Internal Medicine deals with rare autoimmune diseases, of which there is not always a cure. Even when the treatment is optimal, there are often subjective complaints.Patients followed in Internal Medicine therefore have favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. This information will make it possible to target the patient's needs, and to be able to offer alternative medicines that are better focused, without calling into question their conventional treatment

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

121Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire.	Behavioral	patients will respond to a specific questionnaire regarding the use of alternative medicine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients using alternative medicine.	Counting the number of patients using alternative medicine.	At day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
Patient with signed consent

Exclusion criteria:

Patients deprived of their liberty
Minors and adults subject to legal protection measures
Patients subject to a justice safeguard measure
Patient unable to understand or adhere to the protocol

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

Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Médecin Interne A		Limoges			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38346411	Result	Couillard F, Parreau S, Dumonteil S, Ratti N, Palat S, Bezanahary H, Liozon E, Ly KH, Fauchais AL, Gondran G. Use of Complementary and Alternative Medicine by Patients Treated for Systemic Lupus Erythematosus, Primary Sjogren's Syndrome, or Systemic Sclerosis in a French Rural Region. Complement Med Res. 2024;31(3):234-240. doi: 10.1159/000536580. Epub 2024 Feb 12.

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