NCT02665013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
824

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 4, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 13, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

January 4, 2016

Last Update Submit

June 11, 2019

Conditions

Communicable Diseases

Outcome Measures

Primary Outcomes (1)

  • The child's vaccination status

    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 Outcomes (2)

  • Maternal Vaccine attitudes

    12 months

  • Maternal Vaccine values

    12 months

Study Arms (3)

Tailored

EXPERIMENTAL

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

Untailored

PLACEBO COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

TailoredBEHAVIORAL

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.

Tailored
UntailoredBEHAVIORAL

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.

Untailored

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado

Denver, Colorado, 80231, United States

Location

Related Publications (2)

  • Glanz JM, Wagner NM, Narwaney KJ, Pyrzanowski J, Kwan BM, Sevick C, Resnicow K, Dempsey AF. Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial. Pediatrics. 2020 Nov;146(5):e20200669. doi: 10.1542/peds.2020-0669. Epub 2020 Oct 12.

    PMID: 33046584DERIVED

  • Dempsey AF, Wagner N, Narwaney K, Pyrzanowski J, Kwan BM, Kraus C, Gleason K, Resnicow K, Sevick C, Cataldi J, Brewer SE, Glanz JM. 'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination. BMJ Open. 2019 May 22;9(5):e027968. doi: 10.1136/bmjopen-2018-027968.

    PMID: 31122997DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 27, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

June 13, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)