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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02666872
Other study ID # 13-074
Secondary ID 27505
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date January 2019

Study information

Verified date April 2021
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 2719
Est. completion date January 2019
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interviewing


Locations

Country Name City State
Canada CHU Sainte-Justine Montréal Quebec
Canada McGill University Health Centre (Hôpital de Montréal pour enfants) Montréal Quebec
Canada CHU de Québec - CHUL Québec Quebec
Canada Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (5)

Lead Sponsor Collaborator
Université de Sherbrooke CHU de Quebec-Universite Laval, Fonds de la Recherche en Santé du Québec, McGill University Health Centre/Research Institute of the McGill University Health Centre, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 10 months
Secondary 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. 24 months
Secondary 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
Secondary 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
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