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Motivational InterviewingPROMOVAQNCT02666872

Evaluation of an Intervention PROMOting VAccination in Maternity in Quebec

A study testing Motivational interviewing in people with Motivational Interviewing, run by Université de Sherbrooke at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vaccination greatly reduced mortality and morbidity from many preventable diseases. However, to avoid the resurgence of these diseases and the human drama associated, high vaccine coverage should be maintained in the population. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Motivational Interviewing
What is being tested?
Motivational interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,719 participants
Where
4 sitesCanada
Study dates
Jun 2013to Jan 2019
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parents of all infants born in each participating maternity hospitals
  • In Sherbrooke, inclusion limited to parents residing in the region of the Eastern Townships
  • In Québec, inclusion limited to parents residing in the National Capital region.

Who cannot join

  • Minor parents
  • Parents who do not speak English or French
  • Any health condition of the child or the mother needing acute care. That is to say, if the child must be hospitalized in neonatology, or if the mother has an incompatible condition with an interview.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • McGill University Health Centre (Hôpital de Montréal pour enfants)

    Montreal, Quebec, H3H 1P3

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • CHU de Québec - CHUL

    Québec, Quebec, G1V 4G2

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Evaluation of a New Educational Strategy Promoting Vaccination in Maternity in Quebec Based on Motivational Interviewing Techniques: PROMOVAQ Study

Vaccination greatly reduced mortality and morbidity from many preventable diseases. However, to avoid the resurgence of these diseases and the human drama associated, high vaccine coverage should be maintained in the population. Yet in Quebec, vaccine coverage (VC) in young children remains suboptimal, especially caused by a proportion of parents who are ambivalent about the safety and effectiveness of vaccines. In this context, the Provincial Immunization Committee developed in 2010 a Quebec's immunization promotion plan.

Therefore, our research team tested and validated across the Eastern Townships, a vaccination promotion concept by means of an educational intervention within maternities, based on motivational interviewing techniques. This intervention has not only significantly increased the intention of vaccination (+15%) within parents who had received the intervention but also increased their child vaccination coverage (+7.5% at 7 months). This is the purpose of the PROMOVAQ study (PROmotion of VAccination in Quebec) This research project evaluated the impact of an educational strategy based on motivational interviewing techniques within maternity ward on infants' VC. This strategy has been tested through a provincial study (Montreal, Quebec, Sherbrooke) including more than 2500 families.

At term, this research program will offer the Quebec's Health Ministry an optimal strategy for immunization awareness so that Quebec's children may grow healthy and thrive.

Being tested
Motivational interviewing
Keywords
Vaccination, Infant, Parents, Intention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewingBehavioural

Study groups in NCT02666872
Study groupRoleWhat they receive
Motivational interviewing on vaccinationExperimentalAn educational strategy based on motivational interviewing of approximately 15 minutes to promote vaccination, in maternity ward.
Receives: Behavioral: Motivational interviewing
Brochure about vaccines for infantsNo interventionParents in the control group only received a brochure about vaccines for infants. This brochure is given to all fathers and mothers giving birth to the CHUS, participating or not at our study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccination status of the child at 7 months of age

    Data was collected at 10 months of age for all children from regional immunization registries or self-reported by parents over the phone. Vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 7 months of age by the total number of children.

    Measured: 10 months

Secondary outcomes (4)

  1. Vaccination status of the child at 3 and 5 months of age

    Data was collected at 10 months of age for all children from regional immunization registries or self-reported by parents over the phone. Early vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 3 and 5 months of age by the total number of children.

    Measured: 10 months

  2. Vaccination status of the child at 13, 19 and 24 months of age

    Data will be collected at 24 months of age for all children from regional immunization registries or self-reported by parents over the phone. Long-term vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 13, 19 and 24 months of age by the total number of children.

    Measured: 24 months

  3. Intention's parents to vaccination assessed by a questionnaire based on the Health Belief Model

    Measured: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention

  4. Hesitancy 's parents to vaccination by a questionnaire based on the Opel's tool to measure vaccine hesitancy

    Measured: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2015
  4. Study completionJan 2019

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02666872
Sponsor's protocol ID
13-074
Other IDs
27505
Acronym
PROMOVAQ
Status last verified
Apr 2021
First submitted
19 Jan 2016
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.

    PubMed 6863699

  • Gagneur A, Quach C, Boucher FD, Tapiero B, De Wals P, Farrands A, Lemaitre T, Boulianne N, Sauvageau C, Ouakki M, Gosselin V, Gagnon D, Petit G, Jacques MC, Dube E. Promoting vaccination in the province of Quebec: the PromoVaQ randomized controlled trial protocol. BMC Public Health. 2019 Feb 6;19(1):160. doi: 10.1186/s12889-019-6468-z.

    PubMed 30727991

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing in people with Motivational Interviewing, run by Université de Sherbrooke at 4 sites in Canada.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccination status of the child at 7 months of age (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02666872, which also lists 2 linked publications.

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 27 Apr 2021.

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