Vaccine Social Media Randomized Intervention Trial

Communicable Diseases Clinical Trial

— VSMRCT  

Official title:

Randomized Intervention Trial to Evaluate a Vaccine Social Media Website

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873040
• Other study ID #: 1R01HS021492-01
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: October 16, 2017
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the effectiveness of social media website devoted to vaccines to change immunization knowledge, perceptions and behavior. If effective, this intervention will represent an innovative, low cost and broadly applicable resource to reduce parental vaccination concerns.

The study has two hypothesis:

1. Parents receiving usual care plus social media website will demonstrate higher early childhood immunization rates to parents receiving either usual plus non interactive website or usual care only.

2. Parents receiving usual care plus social media website will demonstrate positive changes in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving either usual care plus non-interactive website or usual care only.

Description:

Participants will be enrolled in the study, stratified based on hesitancy and randomly assigned to 1 of 3 study arms and followed for 1-2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1675
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women >20 weeks Pregnant (including parents of children up to 1 year of age).

• >18 years of age

Exclusion Criteria:

• Non english speak

• Do not intend to use Kaiser insurance for the child

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Behavioral:
• Social Media plus information pages
Participants will receive access to the study vaccine website information pages and social media feature including blogs, discussion forums, expert chats, and ask an expert.
• Vaccine Information Pages
Participants will receive access to the study vaccine website information pages.

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado Institute for Health Research	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days under-immunized	Days under-immunized is a metric to identify immunization delay. For each vaccine dose calculate the difference between when the vaccine dose was actually administered and when the vaccine dose should have been administered according to the Advisory Committee on Immunization Practices (ACIP) schedule. That difference is summed across all doses and vaccines for a total number of days under-immunized for each child. Total days under immunized was calculated 200 days after life or after enrollment. If someone had 0 days at that time they were considered "up to date".	2 years
Secondary	Knowledge, Attitudes and Beliefs about immunizations	Knowledge, attitudes, and beliefs will be measured with a survey at up to 3 time points during the study: 1) Initial enrollment in the study, 2) child's ag=4-6 months and 3) child's age=11-13 months.	Baseline, Child age 3-5 months, Child age 12-15 months