Difference Between Patient Vaccine Hesitancy and Percepti... | NCT04313816

Studies
Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy

NCT04313816

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Vaccine Hesitancy

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

ID	Type	Description	Link
2019-A02487-50	Other Identifier	ID RCB

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Mar 17, 2020

First Posted Date

Mar 18, 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

Mar 17, 2020

Last Update Posted Date

Mar 18, 2020Actual

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

The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation:

for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale)
for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other.

Detailed Description

The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation:

for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale)
for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other.

The investigators will recruit 400 to 500 patients in 20 medical practices of general practioners.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
unique group		patients visiting their family physician	Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	no intervention at all apart from filling a brief questionnaire	unique group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy.	Each participant will evaluate hi/her vaccine hesitancy on a 0-100 scale; his/her family physician will also evaluate the vaccine hesitancy of this participant on the same 0-100 scale. The outcome 1 is the difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy (on this 0-100 scale). These are arbitrary units.	one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

visiting the family physician
accepting the study after information

Exclusion Criteria:

none apart from the reverse of inclusion criteria

Accepts Healthy Volunteers

Yes

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

patients visiting their family physician in one participating medical practice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EPAULARD	Recruiting	Grenoble		38000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

non sharing of individual data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000088823	Vaccination Hesitancy

Ancestor Terms

ID	Term
D000072758	Vaccination Refusal
D016312	Treatment Refusal
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

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