InfluenzaNCT02151201
Impact of Influenza Vaccination in Pregnancy Video Education
A study testing Influenza vaccination video education and Hand washing video education in people with Influenza, run by The Cleveland Clinic at 1 site in United States.
Trial summary
We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccination video education and Hand washing video education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant
- English as primary language
- scheduled for a routine prenatal visit
- no documented influenza vaccination 2013-2014
Who cannot join
- Cleveland Clinic Employee
- high risk pregnancy
- allergy to eggs
- allergy to influenza vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Video Education on Influenza Vaccination Rate in Pregnancy
We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate. We hypothesized that the video would positively impact both vaccination health beliefs and vaccination rate compared to a control video.
Read the detailed description
We studied the impact of influenza in pregnancy video education that was developed by the CDC and currently available to the public on the internet. We looked to see if viewing the video just prior to a routine scheduled prenatal visit could positively influence health beliefs regarding vaccination and improve the rate of vaccination that day. Patients were randomized to view the intervention video or a control video of similar length about hand washing. Pre visit and post visit questionnaires were given about vaccination health beliefs. We also asked if the shot had been recommended by the physician. One month after the visit, we used a structured phone interview to gather additional information regarding why participants who had not been vaccinated made that choice.
- Conditions
- Influenza
- Being tested
- Influenza vaccination video education, Hand washing video education
- Keywords
- pregnancy vaccination influenza education
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccination video educationBehavioural
Influenza vaccination video education
Hand washing video educationBehavioural
Hand washing video education
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination video education | Experimental | Influenza vaccination video education Receives: Behavioral: Influenza vaccination video education |
| Hand Washing video education | Placebo comparator | Hand Washing vaccination video education Receives: Behavioral: Hand washing video education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Vaccination Rate
The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit.
Measured: day of the prenatal visit
Secondary outcomes (2)
Influenza Vaccination in Pregnancy Health Beliefs
Measured: day of the prenatal visit
Influenza vaccination in pregnancy health beliefs
health beliefs regarding vaccination were tested on a 5 point likert-type scale before the video intervention and after the prenatal visit.
Measured: Day of the appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Goodman, MD, The Cleveland Clinic
- Investigators
- Kenneth Goodman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151201
- Sponsor's protocol ID
- 13-1157
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Video Education on Influenza Vaccination Rate in Pregnancy
- ClinicalTrials.gov ID
- NCT02151201
- Acronym / sponsor ID
- 13-1157
- Conditions
- Influenza
- Keywords
- pregnancy vaccination influenza education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 May 2014 (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.
We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate. We hypothesized that the video would positively impact both vaccination health beliefs and vaccination rate compared to a control video.
Detailed description
We studied the impact of influenza in pregnancy video education that was developed by the CDC and currently available to the public on the internet. We looked to see if viewing the video just prior to a routine scheduled prenatal visit could positively influence health beliefs regarding vaccination and improve the rate of vaccination that day. Patients were randomized to view the intervention video or a control video of similar length about hand washing. Pre visit and post visit questionnaires were given about vaccination health beliefs. We also asked if the shot had been recommended by the physician. One month after the visit, we used a structured phone interview to gather additional information regarding why participants who had not been vaccinated made that choice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination video education | Experimental | Behavioral: Influenza vaccination video educationInfluenza vaccination video education |
| Hand Washing video education | Placebo comparator | Behavioral: Hand washing video educationHand Washing vaccination video education |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant
- English as primary language
- scheduled for a routine prenatal visit
- no documented influenza vaccination 2013-2014
Key exclusion criteria (4 listed)
- Cleveland Clinic Employee
- high risk pregnancy
- allergy to eggs
- allergy to influenza vaccination
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 |
|---|---|---|
| Influenza vaccination video educationInfluenza vaccination video education | Behavioural | Influenza vaccination video education |
| Hand washing video educationHand washing video education | Behavioural | Hand Washing video education |
Primary outcome
Influenza Vaccination Rate
Time frame: day of the prenatal visit
The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit.
2 secondary outcomes
Influenza Vaccination in Pregnancy Health Beliefs
Time frame: day of the prenatal visit
Influenza vaccination in pregnancy health beliefs
Time frame: Day of the appointment
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 2 Jun 2014.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Kenneth Goodman, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccination video education and Hand washing video education in people with Influenza, run by The Cleveland Clinic 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 4 inclusion and 4 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 2 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Influenza Vaccination Rate (time frame: day of the prenatal visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2014.