Influenza, HumanNCT03332992
Comparative Tests of Flu Vaccination Phone Messages
A study testing Viral changes, Protect others and General intentions in people with Influenza, Human, run by University of Michigan at 1 site in United States.
Trial summary
This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Viral changes, Protect others and General intentions
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,206 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2017to 30 Apr 2018
- 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
- Patient of client organizations of Emmi Solutions
- Provided a phone number to their care team
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.
- Conditions
- Influenza, Human
- Being tested
- Viral changes, Protect others, General intentions, Behavioral intentions, Accountability
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral changesBehavioural
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
Protect othersBehavioural
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
General intentionsBehavioural
Question language asking about general interest in getting influenza vaccination
Behavioral intentionsBehavioural
Question language asking individual to make specific plans to be vaccinated
AccountabilityBehavioural
Question language asking individual whether their care team can learn about their vaccination intentions
| Study group | Role | What they receive |
|---|---|---|
| Viral changes + General intentions | Experimental | Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions). Receives: Behavioral: Viral changes; Behavioral: General intentions |
| Viral changes + Behavioral intentions | Experimental | Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention). Receives: Behavioral: Viral changes; Behavioral: Behavioral intentions |
| Viral changes + Accountability | Experimental | Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers). Receives: Behavioral: Viral changes; Behavioral: Accountability |
| Protect others + General intentions | Experimental | Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions). Receives: Behavioral: Protect others; Behavioral: General intentions |
| Protect others + Behavioral intentions | Experimental | Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention). Receives: Behavioral: Protect others; Behavioral: Behavioral intentions |
| Protect others + Accountability | Experimental | Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers). Receives: Behavioral: Protect others; Behavioral: Accountability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination intentions (Time 1)
Question (language being manipulated) asking whether respondent intends to vaccinate
Measured: Day 1 (Assessed during the intervention telephone call)
Secondary outcomes (1)
Documented influenza vaccination
Documentation (when available from Emmi Solutions' clients) via clients' employee records that influenza vaccination occurred
Measured: Within 6 months / during 2017-2018 influenza season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start11 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Emmi Solutions, University of Iowa, University of Utah
- Responsible party
- Principal investigator, Brian Zikmund-Fisher, University of Michigan
- Investigators
- Brian J Zikmund-Fisher, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332992
- Sponsor's protocol ID
- HUM00135995
- Status last verified
- May 2018
- First submitted
- 30 Oct 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Tests of Flu Vaccination Phone Messages
- ClinicalTrials.gov ID
- NCT03332992
- Acronym / sponsor ID
- HUM00135995
- Conditions
- Influenza, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,206 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Emmi Solutions, University of Iowa, University of Utah
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Nov 2017 (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 project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Viral changes + General intentions | Experimental | Behavioral: Viral changes, Behavioral: General intentionsScript language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions). |
| Viral changes + Behavioral intentions | Experimental | Behavioral: Viral changes, Behavioral: Behavioral intentionsScript language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention). |
| Viral changes + Accountability | Experimental | Behavioral: Viral changes, Behavioral: AccountabilityScript language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers). |
| Protect others + General intentions | Experimental | Behavioral: Protect others, Behavioral: General intentionsScript language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions). |
| Protect others + Behavioral intentions | Experimental | Behavioral: Protect others, Behavioral: Behavioral intentionsScript language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention). |
| Protect others + Accountability | Experimental | Behavioral: Protect others, Behavioral: AccountabilityScript language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient of client organizations of Emmi Solutions
- Provided a phone number to their care team
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Viral changesTelephone script language provided pre-questions regarding the fact that influenza viruses change each year | Behavioural | Viral changes + Accountability, Viral changes + Behavioral intentions, Viral changes + General intentions |
| Protect othersTelephone script language provided pre-questions emphasizing the need to protect vulnerable others | Behavioural | Protect others + Accountability, Protect others + Behavioral intentions, Protect others + General intentions |
| General intentionsQuestion language asking about general interest in getting influenza vaccination | Behavioural | Protect others + General intentions, Viral changes + General intentions |
| Behavioral intentionsQuestion language asking individual to make specific plans to be vaccinated | Behavioural | Protect others + Behavioral intentions, Viral changes + Behavioral intentions |
| AccountabilityQuestion language asking individual whether their care team can learn about their vaccination intentions | Behavioural | Protect others + Accountability, Viral changes + Accountability |
Primary outcome
Vaccination intentions (Time 1)
Time frame: Day 1 (Assessed during the intervention telephone call)
Question (language being manipulated) asking whether respondent intends to vaccinate
1 secondary outcome
Documented influenza vaccination
Time frame: Within 6 months / during 2017-2018 influenza season
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 15 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Brian J Zikmund-Fisher, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viral changes, Protect others and General intentions in people with Influenza, Human, run by University of Michigan 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 1 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 15 May 2018. 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?
Vaccination intentions (Time 1) (time frame: Day 1 (Assessed during the intervention telephone call)). 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 15 May 2018.