Vaccine HesitancyDiffHésiVacNCT04313816
Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy
An observational study of Vaccine Hesitancy, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- questionnaire
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients visiting their family physician in one participating medical practice
Who may be able to join
- visiting the family physician
- accepting the study after information
Who cannot join
- none apart from the reverse of inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
EPAULARD
Grenoble, 38000
Olivier Epaulard, MD, PhD, +336476765291, oepaulard@chu-grenoble.fr
About this study
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.
Read the 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.
- Conditions
- Vaccine Hesitancy
- Being tested
- questionnaire
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called no intervention at all apart from filling a brief questionnaire
no intervention at all apart from filling a brief questionnaire
| Study group | Role | What they receive |
|---|---|---|
| unique group | patients visiting their family physician Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start14 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313816
- Sponsor's protocol ID
- 38RC19.288
- Other IDs
- 2019-A02487-50
- Acronym
- DiffHésiVac
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: non sharing of individual data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT04313816
- Acronym / sponsor ID
- DiffHésiVac / 38RC19.288
- Conditions
- Vaccine Hesitancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unique group | – | Other: questionnairepatients visiting their family physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients visiting their family physician in one participating medical practice
Key inclusion criteria (2 listed)
- visiting the family physician
- accepting the study after information
Key exclusion criteria (1 listed)
- none apart from the reverse of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAlso: no intervention at all apart from filling a brief questionnaireno intervention at all apart from filling a brief questionnaire | Other | unique group |
Primary outcome
difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy.
Time frame: one day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No. non sharing of individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Hesitancy, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between patient's vaccine hesitancy and perception by his/her family physician of his/her vaccine hesitancy. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.