Reducing Delay of Vaccination in Children Study (REDIVAC)

June 11, 2019 updated by: Kaiser Permanente
This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

824

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80231
        • Kaiser Permanente Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored
Participants will complete surveys at each intervention time point. Based on survey responses, they will receive vaccine information on the study website tailored to their vaccine concerns and values
Behavioral: Tailored
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.
Placebo Comparator: Untailored
Participants will complete surveys at each intervention time point and receive vaccine information on the study website. The vaccine information will NOT be tailored to their concerns and values.
Behavioral: Untailored
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.
No Intervention: Usual Care
Participants will complete surveys at each intervention time point. They will receive vaccine information sheets that are provided in the well child visits at enrollment in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The child's vaccination status
Time Frame: 200 days
assessed 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.
200 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Vaccine attitudes
Time Frame: 12 months
Maternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy
12 months
Maternal Vaccine values
Time Frame: 12 months
Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

University of Colorado, Denver
University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD079457-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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