Vaccination HesitancyMOTI-VAC_IMGNCT05565755
Impact on Patients' Vaccine Hesitancy of a Motivational Interviewing Training in Initial Medical Training Course
A study testing Motivational interview in people with Vaccination Hesitancy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccination Hesitancy
- What is being tested?
- Motivational interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 8 Aug 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).
Who cannot join
- Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
- Interns who have already received training at the MI
Trial locations and contacts
1 site in 1 country.
François CREMIEUX contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
About this study
In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended.
Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination).
Read more
The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS.
A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:
- a group of interns trained in MI,
- a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training.
After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation.
Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression.
Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique.
We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.
- Conditions
- Vaccination Hesitancy
- Being tested
- Motivational interview
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewOther
Motivational interview Training
| Study group | Role | What they receive |
|---|---|---|
| Parents of adolescents who had a consultation with a group of IM-trained interns. | Experimental | Not described Receives: Other: Motivational interview |
| Parents of adolescents who have not had a consultation with a group of IM trained interns. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine hesitancy score of parents of adolescents
Score measured using the validated VCS: Vaccination Confidence Scale. This scale is composed of 8 items, each receiving a score ranging from 0 (strongly disagree) to 10 (strongly agree), with the highest score expressing the highest degree of confidence in vaccines and the lowest expressing the highest degree of VH.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
Behaviour, beliefs and knowledge about vaccines
Reponses to Questions about Behaviour, beliefs and knowledge about vaccine
Measured: through study completion, an average of 2 years
Parent and medical intern satisfaction with the consultation
Level of parent satisfaction on a scale (not very satisfied to very satisfied)
Measured: through study completion, an average of 2 years
MI learning, knowledge and skills for vaccination promotion in interns
Score to the motivational interviewing skills in immunization Questionnaire (MISI)
Measured: year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start15 Jul 2020
- Primary completion31 Dec 2022
- Study completion8 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination HesitancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of vaccine hesitancy in parents of adolescents during consultations by 2 different groups of interns: * a group of interns trained in MI * a group of interns not trained in IM The randomization will be done by random draw from the 3rd year list of general medicine interns.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565755
- Sponsor's protocol ID
- 2020-15
- Acronym
- MOTI-VAC_IMG
- Status last verified
- Aug 2023
- First submitted
- 26 Sep 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Patients' Vaccine Hesitancy of a Motivational Interviewing Training in Initial Medical Training Course
- ClinicalTrials.gov ID
- NCT05565755
- Acronym / sponsor ID
- MOTI-VAC_IMG / 2020-15
- Conditions
- Vaccination Hesitancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 8 Aug 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended.
Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination).
The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS.
A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:
- a group of interns trained in MI,
- a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training.
After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation.
Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression.
Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique.
We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of vaccine hesitancy in parents of adolescents during consultations by 2 different groups of interns: * a group of interns trained in MI * a group of interns not trained in IM The randomization will be done by random draw from the 3rd year list of general medicine interns.
| Arm | Type | Receives |
|---|---|---|
| Parents of adolescents who had a consultation with a group of IM-trained interns. | Experimental | Other: Motivational interview |
| Parents of adolescents who have not had a consultation with a group of IM trained interns. | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).
Key exclusion criteria (2 listed)
- Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
- Interns who have already received training at the MI
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 |
|---|---|---|
| Motivational interviewMotivational interview Training | Other | Parents of adolescents who had a consultation with a group of IM-trained interns. |
Primary outcome
Vaccine hesitancy score of parents of adolescents
Time frame: through study completion, an average of 2 years
Score measured using the validated VCS: Vaccination Confidence Scale. This scale is composed of 8 items, each receiving a score ranging from 0 (strongly disagree) to 10 (strongly agree), with the highest score expressing the highest degree of confidence in vaccines and the lowest expressing the highest degree of VH.
3 secondary outcomes
Behaviour, beliefs and knowledge about vaccines
Time frame: through study completion, an average of 2 years
Parent and medical intern satisfaction with the consultation
Time frame: through study completion, an average of 2 years
MI learning, knowledge and skills for vaccination promotion in interns
Time frame: year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
François CREMIEUX contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Vaccination Hesitancy, run by Assistance Publique Hopitaux De Marseille 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 1 inclusion and 2 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 9 Aug 2023. 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?
Contact Eva MITILIAN (0491000000, eva.MITILIAN@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine hesitancy score of parents of adolescents (time frame: through study completion, an average of 2 years). 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 9 Aug 2023.