NCT02666872

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,719

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

January 19, 2016

Last Update Submit

April 26, 2021

Conditions

Motivational Interviewing

Keywords

VaccinationInfantParentsIntention

Outcome Measures

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.

    10 months

Secondary Outcomes (4)

  • Vaccination status of the child at 3 and 5 months of age

    10 months

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

    24 months

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

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

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

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

Study Arms (2)

Motivational interviewing on vaccination

EXPERIMENTAL

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

Behavioral: Motivational interviewing

Brochure about vaccines for infants

NO INTERVENTION

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

Motivational interviewingBEHAVIORAL
Motivational interviewing on vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of all infants born in each participating maternity hospitals

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McGill University Health Centre (Hôpital de Montréal pour enfants)

Montreal, Quebec, H3H 1P3, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Québec - CHUL

Québec, Quebec, G1V 4G2, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 6863699BACKGROUND

  • 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.

    PMID: 30727991DERIVED

Related Links

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Arnaud Gagneur, MD, Ph.D

    Sherbrooke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D, Associate Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 28, 2016

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2019

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

CA(4)