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Vaccine Social Media Randomized Intervention Trial (VSMRCT)

Primary Purpose

Communicable Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media plus information pages
Vaccine Information Pages
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Communicable Diseases focused on measuring Social Media, Vaccine, Immunization

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Colorado Institute for Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Social media plus information pages

Information Pages

Usual Care

Arm Description

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.

Participants will have website access to vaccine information pages.

Participants will not have access to the vaccine website. They will receive pediatric care as usual.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.

Full Information

First Posted
June 5, 2013
Last Updated
October 16, 2017
Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01873040
Brief Title
Vaccine Social Media Randomized Intervention Trial
Acronym
VSMRCT
Official Title
Randomized Intervention Trial to Evaluate a Vaccine Social Media Website
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Diseases
Keywords
Social Media, Vaccine, Immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social media plus information pages
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Pages
Arm Type
Experimental
Arm Description
Participants will have website access to vaccine information pages.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will not have access to the vaccine website. They will receive pediatric care as usual.
Intervention Type
Behavioral
Intervention Name(s)
Social Media plus information pages
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vaccine Information Pages
Intervention Description
Participants will receive access to the study vaccine website information pages.
Primary Outcome Measure Information:
Title
Days under-immunized
Description
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".
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Knowledge, Attitudes and Beliefs about immunizations
Description
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.
Time Frame
Baseline, Child age 3-5 months, Child age 12-15 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Glanz, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Colorado Institute for Health Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31471001
Citation
O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27.
Results Reference
derived
PubMed Identifier
29773490
Citation
Daley MF, Narwaney KJ, Shoup JA, Wagner NM, Glanz JM. Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention. Am J Prev Med. 2018 Jul;55(1):44-54. doi: 10.1016/j.amepre.2018.04.010. Epub 2018 May 14.
Results Reference
derived

Learn more about this trial

Vaccine Social Media Randomized Intervention Trial

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