Communicable DiseasesVSMRCTNCT01873040
Vaccine Social Media Randomized Intervention Trial
A study testing Social Media plus information pages and Vaccine Information Pages in people with Communicable Diseases, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Communicable Diseases
- What is being tested?
- Social Media plus information pages and Vaccine Information Pages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,675 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women >20 weeks Pregnant (including parents of children up to 1 year of age).
- >18 years of age
Who cannot join
- Non english speak
- Do not intend to use Kaiser insurance for the child
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Colorado Institute for Health Research
Denver, Colorado, 80231
About this study
Official title: Randomized Intervention Trial to Evaluate a Vaccine Social Media Website
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.
Read the 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.
- Conditions
- Communicable Diseases
- Being tested
- Social Media plus information pages, Vaccine Information Pages
- Keywords
- Social Media, Vaccine, Immunization
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media plus information pagesBehavioural
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 PagesBehavioural
Participants will receive access to the study vaccine website information pages.
| Study group | Role | What they receive |
|---|---|---|
| Social media plus information pages | Experimental | 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. Receives: Behavioral: Social Media plus information pages |
| Information Pages | Experimental | Participants will have website access to vaccine information pages. Receives: Behavioral: Vaccine Information Pages |
| Usual Care | No intervention | Participants will not have access to the vaccine website. They will receive pediatric care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 2 years
Secondary outcomes (1)
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.
Measured: Baseline, Child age 3-5 months, Child age 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Communicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jason M Glanz, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873040
- Sponsor's protocol ID
- 1R01HS021492-01
- Acronym
- VSMRCT
- Status last verified
- Oct 2017
- First submitted
- 5 Jun 2013
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31471001Daley 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.
PubMed 29773490
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Intervention Trial to Evaluate a Vaccine Social Media Website
- ClinicalTrials.gov ID
- NCT01873040
- Acronym / sponsor ID
- VSMRCT / 1R01HS021492-01
- Conditions
- Communicable Diseases
- Keywords
- Social Media, Vaccine, Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,675 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social media plus information pages | Experimental | Behavioral: Social Media plus information pagesParticipants 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. |
| Information Pages | Experimental | Behavioral: Vaccine Information PagesParticipants will have website access to vaccine information pages. |
| Usual Care | No intervention | –Participants will not have access to the vaccine website. They will receive pediatric care as usual. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women >20 weeks Pregnant (including parents of children up to 1 year of age).
- >18 years of age
Key exclusion criteria (2 listed)
- Non english speak
- Do not intend to use Kaiser insurance for the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Media plus information pagesParticipants will receive access to the study vaccine website information pages and social media feature including blogs, discussion forums, expert chats, and ask an expert. | Behavioural | Social media plus information pages |
| Vaccine Information PagesParticipants will receive access to the study vaccine website information pages. | Behavioural | Information Pages |
Primary outcome
Days under-immunized
Time frame: 2 years
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".
1 secondary outcome
Knowledge, Attitudes and Beliefs about immunizations
Time frame: Baseline, Child age 3-5 months, Child age 12-15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Derived from this study: PubMed 31471001O'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.
- Derived from this study: PubMed 29773490Daley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M Glanz, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media plus information pages and Vaccine Information Pages in people with Communicable Diseases, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days under-immunized (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873040, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.