Vaccine Social Media Randomized Intervention Trial (VSMRCT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01873040
First received: June 5, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Vaccination Delay
Behavioral: Social Media plus vaccine information pages
Behavioral: Vaccine Information Pages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Intervention Trial to Evaluate a Vaccine Social Media Website

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Days under-immunized [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Knowledge, Attitudes and Beliefs about immunizations [ Time Frame: Baseline, Child age 4-6 months, Child age 11-13 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: August 2013
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social media plus vaccine information pages
Participants will have access to the vaccine social media website with information pages and social media features including discussion forums, blogs, chat with an expert, and ask an expert.
Behavioral: Social Media plus vaccine 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.
Experimental: Information Pages
Participants will have website access to vaccine information pages.
Behavioral: Vaccine Information Pages
No Intervention: Usual Care
Participants will not have access to the vaccine website. They will receive pediatric care as usual.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women >20 weeks Pregnant
  • >18 years of age

Exclusion Criteria:

  • Non english speak
  • Do not intend to use Kaiser insurance for the child
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873040

Locations
United States, Colorado
Kaiser Permanente Colorado Institute for Health Research
Denver, Colorado, United States, 80231
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Jason M Glanz, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01873040     History of Changes
Other Study ID Numbers: 1R01HS021492-01
Study First Received: June 5, 2013
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Kaiser Permanente:
Social Media
Vaccine
Immunization

ClinicalTrials.gov processed this record on October 20, 2014