Influenza, VaccinationNCT03700281
Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
A study testing Messaging and Incentive in people with Influenza, Vaccination, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
Trial summary
This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccination
- What is being tested?
- Messaging and Incentive
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,584 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2018to 31 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrollment in Sendero IdealCare health plan as of August 1, 2018
- Age 18 years or older
Who cannot join
- A coverage termination date listed prior to December 31, 2018.
- Sendero member records lack both a phone number and email address.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas System Population Health
Austin, Texas, 78701
About this study
- This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.
- Conditions
- Influenza, Vaccination
- Being tested
- Messaging, Incentive
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MessagingBehavioural
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
IncentiveBehavioural
Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Messaging | Experimental | Group will be sent flu vaccine promotion messages via text, email and U.S. Mail Receives: Behavioral: Messaging |
| Messaging plus incentive | Experimental | Group will be sent flu vaccine promotion messages via text, email and U.S. Mail, and will be eligible to receive a gift card as incentive for receiving flu vaccine Receives: Behavioral: Messaging; Behavioral: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination
Receipt of an influenza vaccination documented by medical or pharmacy claim.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start6 Oct 2018
- Primary completion31 Mar 2019
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, VaccinationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Sendero Health Plans, Inc.
- Responsible party
- Principal investigator, Eileen Nehme, The University of Texas Health Science Center at Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700281
- Sponsor's protocol ID
- SenderoFlu2018
- Status last verified
- Apr 2019
- First submitted
- 4 Oct 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
- ClinicalTrials.gov ID
- NCT03700281
- Acronym / sponsor ID
- SenderoFlu2018
- Conditions
- Influenza, Vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22,584 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Sendero Health Plans, Inc.
- Study start
- 6 Oct 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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 effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Messaging | Experimental | Behavioral: MessagingGroup will be sent flu vaccine promotion messages via text, email and U.S. Mail |
| Messaging plus incentive | Experimental | Behavioral: Messaging, Behavioral: IncentiveGroup will be sent flu vaccine promotion messages via text, email and U.S. Mail, and will be eligible to receive a gift card as incentive for receiving flu vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrollment in Sendero IdealCare health plan as of August 1, 2018
- Age 18 years or older
Key exclusion criteria (2 listed)
- A coverage termination date listed prior to December 31, 2018.
- Sendero member records lack both a phone number and email address.
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 |
|---|---|---|
| MessagingThe participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans. | Behavioural | Messaging, Messaging plus incentive |
| IncentiveParticipants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine | Behavioural | Messaging plus incentive |
Primary outcome
Influenza vaccination
Time frame: three months
Receipt of an influenza vaccination documented by medical or pharmacy claim.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Messaging and Incentive in people with Influenza, Vaccination, run by The University of Texas Health Science Center at Tyler 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. 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?
Results are not available in the source record.
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 (time frame: three months). 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 23 Apr 2019.