Influenza, HumanNCT04590066
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
A study testing Flu shot text messages in people with Influenza, Human, run by University of Pennsylvania at 1 site in United States.
Trial summary
This research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. Past behavioral science interventions have shown promise in increasing flu vaccinations. 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?
- Flu shot text messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 734,383 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 31 Dec 2020
- 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
- Have agreed to receive SMS messages from the pharmacy
- Received a flu shot from the pharmacy in the 2019-2020 flu season, as documented in their pharmacy records.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. Past behavioral science interventions have shown promise in increasing flu vaccinations. For example, successful interventions have encouraged people to make concrete plans for when they will get a flu vaccination, sent automated calls or text messages reminding patients to get a flu vaccination , or provided financial incentives for getting vaccinated. Although these results are promising, these studies have been conducted in isolation on different populations, which makes it difficult to compare their interventions' effectiveness or to have enough power to reliably detect differing responses to interventions based on individual characteristics.
This research will simultaneously test 22 different SMS interventions to increase flu vaccinations compared to a holdout control condition in a "mega-study" and apply machine learning to identify which interventions work best for whom. The interventions are designed by behavioral science experts from the Behavior Change for Good Initiative (BCFG), Penn Medicine Nudge Unit (PMNU), and Geisinger Behavioral Insights Team (BIT). Customers of a large retail pharmacy who received a flu shot from the pharmacy last year and receive SMS notifications will be included in this study. We expect this to include approximately 1.2 million participants.
The specific aims of this research are to identify (1) which behavioral science strategies effectively increase flu vaccination rates overall, and (2) which strategies are most effective for different subgroups (e.g., based on age, gender, race).
- Conditions
- Influenza, Human
- Being tested
- Flu shot text messages
- Keywords
- Influenza vaccination, behavioral science interventions, vaccination promotion
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu shot text messagesBehavioural
Participants will receive text messages per descriptions listed in the arms.
| Study group | Role | What they receive |
|---|---|---|
| Holdout control | No intervention | Participants will only receive the standard pharmacy messaging. |
| Unpacking Risks Treatment | Experimental | Participants will be asked to think about the risks of catching the flu this flu season and to respond with the location they are most likely to catch the flu out of a list of given options (e.g. at work, at home). Receives: Behavioral: Flu shot text messages |
| Unpacking Risks Control | Experimental | Participants will be asked to think about the risks of catching the flu this flu season and to respond to confirm that they have received the message. Receives: Behavioral: Flu shot text messages |
| Active Commitment Treatment | Experimental | Participants receive a gain framed notification that they are eligible for a flu shot. In addition, participants are told "Many people find it helpful to make a plan to get their shot" and are asked to commit by texting back "I will get a flu shot." Depending on their response, participants receive a general reminder or a commitment reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Active Commitment Control | Experimental | Participants receive a gain framed notification that they are eligible for a flu shot. Participants receive a general reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Self-Generated Social Norms Treatment | Experimental | Participants will first receive a message enjoining them to consider 2 peers who would want them to vaccinate. Then they will be asked to do those peers a favor by getting a vaccine at their next opportunity. They will receive a reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Self-Generated Social Norms Control | Experimental | articipants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Foot-in-the-Door Treatment | Experimental | Participants will first receive a message enjoining them to encourage someone else to receive a flu vaccine this year. They will then be given a message that they might copy-paste to forward to friends, thereby lowering the effort costs of messaging others. They will receive a reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Foot-in-the-Door Control | Experimental | Participants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later. Receives: Behavioral: Flu shot text messages |
| Prosocial Condition | Experimental | Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also give prosocial reasons for vaccinating (i.e., protecting loved ones; preserving scarce resources). Receives: Behavioral: Flu shot text messages |
| Self-Oriented Condition | Experimental | Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. Receives: Behavioral: Flu shot text messages |
| Prosocial + COVID-19 | Experimental | Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also give prosocial reasons for vaccinating (e.g., protecting loved ones; preserving scarce resources). The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources). Receives: Behavioral: Flu shot text messages |
| Self-Oriented + COVID-19 | Experimental | Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources). Receives: Behavioral: Flu shot text messages |
| Dynamic + Static Norm | Experimental | Participants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before and how many Americans got their flu shot last year. Receives: Behavioral: Flu shot text messages |
| Dynamic Norm | Experimental | Participants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before. Receives: Behavioral: Flu shot text messages |
| Dynamic Norms Control | Experimental | Participants will only receive a text message encouraging them to get a flu shot. They will not receive any norm information. Receives: Behavioral: Flu shot text messages |
| Sharing Humor | Experimental | Participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists. Receives: Behavioral: Flu shot text messages |
| Humor Placebo | Experimental | Participants will receive a text message encouraging them to get the flu shot. This message will include the same joke but participants will not be encouraged to share it. Receives: Behavioral: Flu shot text messages |
| No Humor Condition | Experimental | Participants will receive a text message encouraging them to get the flu shot. Receives: Behavioral: Flu shot text messages |
| Connecting the Past Self to the Future Self Treatment | Experimental | Participants will receive a text message prompt to recall the negative experience of getting sick. When asked, "Do you wish you could have avoided getting sick by getting a simple shot?", participants will have the chance to respond Y for yes or N for no. Regardless of their response, they will be prompted with a second text message to connect their past experience with present-day opportunities for preventative care (getting a flu shot) to protect the future self from the flu. Receives: Behavioral: Flu shot text messages |
| Connecting the Past Self to the Future Self Control | Experimental | In the first text message, participants will receive a simple text message encouragement to receive a flu shot. In the second text message, they will receive a reminder of the appointment time and provider name. Receives: Behavioral: Flu shot text messages |
| Reverse Inference Condition | Experimental | Participants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are healthier, wealthier, and more educated. Receives: Behavioral: Flu shot text messages |
| Reverse Inference Control Condition | Experimental | Participants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are less likely to get the flu. Receives: Behavioral: Flu shot text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether participants receive a flu shot vaccination at our pharmacy partner by December 31, 2020
The primary outcome measure is whether participants receive a flu shot at our retail pharmacy partner by December 31, 2020 (as recorded in their pharmacy records) after receiving the SMS intervention on September 25, 2020.
Participants who receive a flu shot before September 25, 2020 when they received the SMS intervention will be excluded from the analyses.
Measured: 98 days
Secondary outcomes (1)
Whether participants receive a flu shot vaccination at our pharmacy partner by October 31, 2020
The secondary outcome measure is whether participants receive a flu shot at our retail pharmacy partner by October 31, 2020 (as recorded in their pharmacy records) after receiving the SMS intervention on September 25, 2020.
Participants who receive a flu shot before they receive the SMS intervention on September 25, 2020 will be excluded from the analyses.
Measured: 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Model description
- Participants will be randomly assigned to the different arms.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 734,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590066
- Sponsor's protocol ID
- 843523-Trial B
- Status last verified
- Jan 2021
- First submitted
- 2 Oct 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutrona SL, Golden JG, Goff SL, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):659-667. doi: 10.1007/s11606-017-4266-9. Epub 2018 Jan 30.
PubMed 29383550Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13.
PubMed 21670283Regan AK, Bloomfield L, Peters I, Effler PV. Randomized Controlled Trial of Text Message Reminders for Increasing Influenza Vaccination. Ann Fam Med. 2017 Nov;15(6):507-514. doi: 10.1370/afm.2120.
PubMed 29133488Nowalk MP, Lin CJ, Toback SL, Rousculp MD, Eby C, Raymund M, Zimmerman RK. Improving influenza vaccination rates in the workplace: a randomized trial. Am J Prev Med. 2010 Mar;38(3):237-46. doi: 10.1016/j.amepre.2009.11.011. Epub 2009 Dec 24.
PubMed 20036102
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
- ClinicalTrials.gov ID
- NCT04590066
- Acronym / sponsor ID
- 843523-Trial B
- Conditions
- Influenza, Human
- Keywords
- Influenza vaccination, behavioral science interventions, vaccination promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734,383 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Oct 2020 (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 research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. Past behavioral science interventions have shown promise in increasing flu vaccinations. For example, successful interventions have encouraged people to make concrete plans for when they will get a flu vaccination, sent automated calls or text messages reminding patients to get a flu vaccination , or provided financial incentives for getting vaccinated. Although these results are promising, these studies have been conducted in isolation on different populations, which makes it difficult to compare their interventions' effectiveness or to have enough power to reliably detect differing responses to interventions based on individual characteristics.
This research will simultaneously test 22 different SMS interventions to increase flu vaccinations compared to a holdout control condition in a "mega-study" and apply machine learning to identify which interventions work best for whom. The interventions are designed by behavioral science experts from the Behavior Change for Good Initiative (BCFG), Penn Medicine Nudge Unit (PMNU), and Geisinger Behavioral Insights Team (BIT). Customers of a large retail pharmacy who received a flu shot from the pharmacy last year and receive SMS notifications will be included in this study. We expect this to include approximately 1.2 million participants.
The specific aims of this research are to identify (1) which behavioral science strategies effectively increase flu vaccination rates overall, and (2) which strategies are most effective for different subgroups (e.g., based on age, gender, race).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 23
- Model description
- Participants will be randomly assigned to the different arms.
| Arm | Type | Receives |
|---|---|---|
| Holdout control | No intervention | –Participants will only receive the standard pharmacy messaging. |
| Unpacking Risks Treatment | Experimental | Behavioral: Flu shot text messagesParticipants will be asked to think about the risks of catching the flu this flu season and to respond with the location they are most likely to catch the flu out of a list of given options (e.g. at work, at home). |
| Unpacking Risks Control | Experimental | Behavioral: Flu shot text messagesParticipants will be asked to think about the risks of catching the flu this flu season and to respond to confirm that they have received the message. |
| Active Commitment Treatment | Experimental | Behavioral: Flu shot text messagesParticipants receive a gain framed notification that they are eligible for a flu shot. In addition, participants are told "Many people find it helpful to make a plan to get their shot" and are asked to commit by texting back "I will get a flu shot." Depending on their response, participants receive a general reminder or a commitment reminder 3 days later. |
| Active Commitment Control | Experimental | Behavioral: Flu shot text messagesParticipants receive a gain framed notification that they are eligible for a flu shot. Participants receive a general reminder 3 days later. |
| Self-Generated Social Norms Treatment | Experimental | Behavioral: Flu shot text messagesParticipants will first receive a message enjoining them to consider 2 peers who would want them to vaccinate. Then they will be asked to do those peers a favor by getting a vaccine at their next opportunity. They will receive a reminder 3 days later. |
| Self-Generated Social Norms Control | Experimental | Behavioral: Flu shot text messagesarticipants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later. |
| Foot-in-the-Door Treatment | Experimental | Behavioral: Flu shot text messagesParticipants will first receive a message enjoining them to encourage someone else to receive a flu vaccine this year. They will then be given a message that they might copy-paste to forward to friends, thereby lowering the effort costs of messaging others. They will receive a reminder 3 days later. |
| Foot-in-the-Door Control | Experimental | Behavioral: Flu shot text messagesParticipants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later. |
| Prosocial Condition | Experimental | Behavioral: Flu shot text messagesParticipants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also give prosocial reasons for vaccinating (i.e., protecting loved ones; preserving scarce resources). |
| Self-Oriented Condition | Experimental | Behavioral: Flu shot text messagesParticipants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. |
| Prosocial + COVID-19 | Experimental | Behavioral: Flu shot text messagesParticipants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also give prosocial reasons for vaccinating (e.g., protecting loved ones; preserving scarce resources). The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources). |
| Self-Oriented + COVID-19 | Experimental | Behavioral: Flu shot text messagesParticipants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot. The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources). |
| Dynamic + Static Norm | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before and how many Americans got their flu shot last year. |
| Dynamic Norm | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before. |
| Dynamic Norms Control | Experimental | Behavioral: Flu shot text messagesParticipants will only receive a text message encouraging them to get a flu shot. They will not receive any norm information. |
| Sharing Humor | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists. |
| Humor Placebo | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get the flu shot. This message will include the same joke but participants will not be encouraged to share it. |
| No Humor Condition | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get the flu shot. |
| Connecting the Past Self to the Future Self Treatment | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message prompt to recall the negative experience of getting sick. When asked, "Do you wish you could have avoided getting sick by getting a simple shot?", participants will have the chance to respond Y for yes or N for no. Regardless of their response, they will be prompted with a second text message to connect their past experience with present-day opportunities for preventative care (getting a flu shot) to protect the future self from the flu. |
| Connecting the Past Self to the Future Self Control | Experimental | Behavioral: Flu shot text messagesIn the first text message, participants will receive a simple text message encouragement to receive a flu shot. In the second text message, they will receive a reminder of the appointment time and provider name. |
| Reverse Inference Condition | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are healthier, wealthier, and more educated. |
| Reverse Inference Control Condition | Experimental | Behavioral: Flu shot text messagesParticipants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are less likely to get the flu. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have agreed to receive SMS messages from the pharmacy
- Received a flu shot from the pharmacy in the 2019-2020 flu season, as documented in their pharmacy records.
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 |
|---|---|---|
| Flu shot text messagesParticipants will receive text messages per descriptions listed in the arms. | Behavioural | Active Commitment Control, Active Commitment Treatment, Connecting the Past Self to the Future Self Control, Connecting the Past Self to the Future Self Treatment, Dynamic + Static Norm, Dynamic Norm, Dynamic Norms Control, Foot-in-the-Door Control, Foot-in-the-Door Treatment, Humor Placebo, No Humor Condition, Prosocial + COVID-19, Prosocial Condition, Reverse Inference Condition, Reverse Inference Control Condition, Self-Generated Social Norms Control, Self-Generated Social Norms Treatment, Self-Oriented + COVID-19, Self-Oriented Condition, Sharing Humor, Unpacking Risks Control, Unpacking Risks Treatment |
Primary outcome
Whether participants receive a flu shot vaccination at our pharmacy partner by December 31, 2020
Time frame: 98 days
The primary outcome measure is whether participants receive a flu shot at our retail pharmacy partner by December 31, 2020 (as recorded in their pharmacy records) after receiving the SMS intervention on September 25, 2020. Participants who receive a flu shot before September 25, 2020 when they received the SMS intervention will be excluded from the analyses.
1 secondary outcome
Whether participants receive a flu shot vaccination at our pharmacy partner by October 31, 2020
Time frame: 37 days
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 1 Feb 2021.
- Background: PubMed 29383550Cutrona SL, Golden JG, Goff SL, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):659-667. doi: 10.1007/s11606-017-4266-9. Epub 2018 Jan 30.
- Background: PubMed 21670283Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13.
- Background: PubMed 29133488Regan AK, Bloomfield L, Peters I, Effler PV. Randomized Controlled Trial of Text Message Reminders for Increasing Influenza Vaccination. Ann Fam Med. 2017 Nov;15(6):507-514. doi: 10.1370/afm.2120.
- Background: PubMed 20036102Nowalk MP, Lin CJ, Toback SL, Rousculp MD, Eby C, Raymund M, Zimmerman RK. Improving influenza vaccination rates in the workplace: a randomized trial. Am J Prev Med. 2010 Mar;38(3):237-46. doi: 10.1016/j.amepre.2009.11.011. Epub 2009 Dec 24.
- 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 Flu shot text messages in people with Influenza, Human, run by University of Pennsylvania 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 1 Feb 2021. 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?
Whether participants receive a flu shot vaccination at our pharmacy partner by December 31, 2020 (time frame: 98 days). 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 NCT04590066, which also lists 4 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 1 Feb 2021.