NCT04496453

Brief Summary

The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

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

July 24, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

July 24, 2020

Results QC Date

March 14, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

childhood vaccinesvaccine hesitancyvaccination

Outcome Measures

Primary Outcomes (2)

  • Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire

    Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.

    pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

  • Change in Acceptability of Childhood Vaccinations

    pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

Study Arms (1)

Childhood vaccination decision support tool

EXPERIMENTAL

Participants receive childhood vaccination decision support tool

Other: Childhood vaccination decision support tool

Interventions

Participants receive childhood vaccination decision support tool

Childhood vaccination decision support tool

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
  • Fluent in English

You may not qualify if:

  • Unable to understand the study objectives, procedures, risks, and benefits
  • Unable to consent for themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Vaccination RefusalVaccination Hesitancy

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Lavanya Vasudevan, Ph.D., M.P.H., C.P.H.
Organization
Emory University

Study Officials

  • Lavanya Vasudevan, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

August 3, 2020

Study Start

December 14, 2020

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

April 18, 2023

Results First Posted

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations