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CompletedNCT02666872PROMOVAQUpdated Apr 27, 2021

Evaluation of an Intervention PROMOting VAccination in Maternity in Quebec

An interventional study of Motivational interviewing in Motivational Interviewing, sponsored by Université de Sherbrooke. Completed at 4 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,719
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Motivational Interviewing

Keywords

  • Vaccination
  • Infant
  • Parents
  • Intention
03

In context

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,719 participants (actual)

Study arms

  • Experimental
    Motivational interviewing on vaccination

    An educational strategy based on motivational interviewing of approximately 15 minutes to promote vaccination, in maternity ward.

    Behavioral: Motivational interviewing

  • No intervention
    Brochure about vaccines for infants

    Parents 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.

Interventions

  • BehavioralMotivational interviewing
06

What researchers measure

Primary outcomes

  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.

    Time frame: 10 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 24 months

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

    Time frame: 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

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

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Study locations

4 sites
  • McGill University Health Centre (Hôpital de Montréal pour enfants)
    Montréal, Quebec H3H 1P3, Canada
  • CHU Sainte-Justine
    Montréal, Quebec H3T 1C5, Canada
  • CHU de Québec - CHUL
    Québec, Quebec G1V 4G2, Canada
  • Centre hospitalier universitaire de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02666872
Lead sponsor
Université de Sherbrooke
Collaborators
CHU de Quebec-Universite Laval, St. Justine's Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, Fonds de la Recherche en Santé du Québec
Responsible party
Arnaud Gagneur (MD, Ph.D, Associate Professor, Université de Sherbrooke) — Principal investigator
First posted
Jan 28, 2016
Start date
Jun 2013
Primary completion
Dec 2015
Completion
Jan 2019
Last update
Apr 27, 2021

Study contacts

Arnaud Gagneur, MD, Ph.D
principal investigator · Sherbrooke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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