Covid19NCT04871776
Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
A study testing Messaging informed by construal level theory in people with Covid19 and Vaccine Refusal, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Vaccine Refusal
- What is being tested?
- Messaging informed by construal level theory
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,671 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the Mass General Brigham system
- Aged 18 and older
- Are eligible for the COVID booster vaccine but have not received a dose at time of upcoming primary care clinic visit
Who cannot join
- Documented allergy to a COVID vaccine or its components
- Home address outside of Massachusetts
- Did not receive full set of primary COVID-19 vaccination series
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.
- Conditions
- Covid19, Vaccine Refusal
- Being tested
- Messaging informed by construal level theory, Usual Care
- Medical subject headings
- COVID-19, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messaging informed by construal level theoryBehavioural
Messages are informed by construal level theory, which suggests that emphasizing "why" elicits more abstract thinking, or high-level construals, and can induce an emotional mindset, which could challenge an individual's sense of identity, autonomy, or political preferences. Conversely, emphasizing "how" is more cognitive and evokes concrete thinking, or low-level construals, and encourages a planning or implementation mindset, which may be better for encouraging vaccine uptake.
Usual CareBehavioural
Usual messaging sent by Mass General Brigham
| Study group | Role | What they receive |
|---|---|---|
| "Why" messaging | Experimental | In this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. Messages will focus on reasons to get the COVID booster vaccine, including protecting self and loved ones or the idea of herd immunity. Receives: Behavioral: Messaging informed by construal level theory |
| "How" messaging | Experimental | In this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. "How" messages will focus on the details of obtaining a vaccination at MGB, what to expect, and how to prepare for the visit. Receives: Behavioral: Messaging informed by construal level theory |
| Usual Care | Active comparator | In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received a Booster Vaccination Through the Targeted Visit
Number of participants who received one dose of a COVID booster vaccine between randomization through the date of the scheduled visit, determined through electronic health records.
Measured: 2-5 days
Secondary outcomes (1)
Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit
Number of participants who received one dose of a COVID booster vaccine between randomization through 6 weeks after the targeted visit, determined through electronic health records.
Measured: 6 weeks after the target visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start18 Feb 2022
- Primary completion27 May 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nancy Haff, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871776
- Sponsor's protocol ID
- 2021P001308
- Other IDs
- P30AG064199
- Status last verified
- Dec 2023
- First submitted
- 30 Apr 2021
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haff N, Choudhry NK, Bhatkhande G, Keller PA, Robertson T, Oran R, Horn D, Crum KL, Oduol T, Hanken K, Lauffenburger JC. "How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial. J Gen Intern Med. 2024 Mar;39(4):611-618. doi: 10.1007/s11606-023-08492-x. Epub 2023 Nov 6.
PubMed 37932539
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
- ClinicalTrials.gov ID
- NCT04871776
- Acronym / sponsor ID
- 2021P001308
- Conditions
- Covid19, Vaccine Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,671 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Why" messaging | Experimental | Behavioral: Messaging informed by construal level theoryIn this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. Messages will focus on reasons to get the COVID booster vaccine, including protecting self and loved ones or the idea of herd immunity. |
| "How" messaging | Experimental | Behavioral: Messaging informed by construal level theoryIn this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. "How" messages will focus on the details of obtaining a vaccination at MGB, what to expect, and how to prepare for the visit. |
| Usual Care | Active comparator | Behavioral: Usual CareIn this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the Mass General Brigham system
- Aged 18 and older
- Are eligible for the COVID booster vaccine but have not received a dose at time of upcoming primary care clinic visit
Key exclusion criteria (3 listed)
- Documented allergy to a COVID vaccine or its components
- Home address outside of Massachusetts
- Did not receive full set of primary COVID-19 vaccination series
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 |
|---|---|---|
| Messaging informed by construal level theoryMessages are informed by construal level theory, which suggests that emphasizing "why" elicits more abstract thinking, or high-level construals, and can induce an emotional mindset, which could challenge an individual's sense of identity, autonomy, or political preferences. Conversely, emphasizing "how" is more cognitive and evokes concrete thinking, or low-level construals, and encourages a planning or implementation mindset, which may be better for encouraging vaccine uptake. | Behavioural | "How" messaging, "Why" messaging |
| Usual CareUsual messaging sent by Mass General Brigham | Behavioural | Usual Care |
Primary outcome
Number of Participants Who Received a Booster Vaccination Through the Targeted Visit
Time frame: 2-5 days
Number of participants who received one dose of a COVID booster vaccine between randomization through the date of the scheduled visit, determined through electronic health records.
1 secondary outcome
Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit
Time frame: 6 weeks after the target visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37932539Haff N, Choudhry NK, Bhatkhande G, Keller PA, Robertson T, Oran R, Horn D, Crum KL, Oduol T, Hanken K, Lauffenburger JC. "How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial. J Gen Intern Med. 2024 Mar;39(4):611-618. doi: 10.1007/s11606-023-08492-x. Epub 2023 Nov 6.
- 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 informed by construal level theory in people with Covid19 and Vaccine Refusal, run by Brigham and Women's Hospital 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 3 inclusion and 3 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 16 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received a Booster Vaccination Through the Targeted Visit (time frame: 2-5 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 NCT04871776, which also lists 1 linked publication.
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 16 Jan 2024.