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Reducing Delay of Vaccination in Children Study

Reducing Delay of Vaccination in Children Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665013
Acronym
REDIVAC
Enrollment
824
Registered
2016-01-27
Start date
2016-04-30
Completion date
2019-05-31
Last updated
2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communicable Diseases

Brief summary

This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

Detailed description

This intervention is based on the concept of message tailoring, whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations. In this three-armed trial the investigator will examine how providing mothers with multiple doses of a tailored versus untailored version of our intervention compares with usual care for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.

Interventions

BEHAVIORALTailored

Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the tailored intervention arm will receive vaccine information tailored specific to her concerns and values at each intervention point.

BEHAVIORALUntailored

Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the untailored arm will receive vaccine information at each intervention time point, but it will not be tailored to her specific concerns.

Sponsors

University of Colorado, Denver
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.

Exclusion criteria

* less then 18 years of age, non-english speaking and an inability to consent

Design outcomes

Primary

MeasureTime frameDescription
The child's vaccination status200 daysassessed using both a continuous and dichotomous measure. Continuous: measure of average days under-vaccinated is a recently developed metric measuring the average number of days a child is unvaccinated based on the vaccines given and the date when the vaccines where given. Dichotomous: mesauring the child's days undervaccinated or whether or not the child is up-to-date with no vaccination delays.

Secondary

MeasureTime frameDescription
Maternal Vaccine attitudes12 monthsMaternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy
Maternal Vaccine values12 monthsHealth values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026