Seasonal InfluenzaNCT01207232
The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
A study testing Planning Prompt in people with Seasonal Influenza, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Planning Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,272 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vaccine indications according to fall 2009 CDC criteria (age >= 50 or chronic disease
- Employee at partner corporation that implemented the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates.
Read the detailed description
Seasonal influenza causes 20,000 hospitalizations and 36,000 deaths in the U.S. each year. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. This type of planning prompt is a "nudge" in the direction of desired behavior that can be implemented at minimal expense and does not restrict individual autonomy. We conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates. We show that planning prompts can be successfully applied to improve health behaviors.
- Conditions
- Seasonal Influenza
- Being tested
- Planning Prompt, Control Condition
- Keywords
- seasonal influenza, behavioral economics, implementation intentions, planning prompt, nudge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning PromptBehavioural
A prompt to write down a planned date (or date and time) for getting a flu shot
Control ConditionBehavioural
A basic reminder mailing prompted each subject to get their flu shot.
| Study group | Role | What they receive |
|---|---|---|
| Time Plan Condition | Experimental | A basic reminder mailing prompted each subject to write down a planned date and time for getting their flu shot. Receives: Behavioral: Planning Prompt |
| Date Plan Condition | Experimental | A basic reminder mailing prompted each subject to write down a planned date for getting their flu shot. Receives: Behavioral: Planning Prompt |
| Control Condition | Active comparator | A basic reminder mailing prompted each subject to receive a flu shot. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of 2009 Seasonal Influenza Vaccination
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal InfluenzaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Yale University, Stanford University
- Investigators
- Katherine L Milkman, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207232
- Sponsor's protocol ID
- 810589-1
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
- ClinicalTrials.gov ID
- NCT01207232
- Acronym / sponsor ID
- 810589-1
- Conditions
- Seasonal Influenza
- Keywords
- seasonal influenza, behavioral economics, implementation intentions, planning prompt, nudge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,272 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Harvard University, Yale University, Stanford University
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Sep 2010 (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.
The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates.
Detailed description
Seasonal influenza causes 20,000 hospitalizations and 36,000 deaths in the U.S. each year. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. This type of planning prompt is a "nudge" in the direction of desired behavior that can be implemented at minimal expense and does not restrict individual autonomy. We conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates. We show that planning prompts can be successfully applied to improve health behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time Plan Condition | Experimental | Behavioral: Planning PromptA basic reminder mailing prompted each subject to write down a planned date and time for getting their flu shot. |
| Date Plan Condition | Experimental | Behavioral: Planning PromptA basic reminder mailing prompted each subject to write down a planned date for getting their flu shot. |
| Control Condition | Active comparator | Behavioral: Control ConditionA basic reminder mailing prompted each subject to receive a flu shot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vaccine indications according to fall 2009 CDC criteria (age >= 50 or chronic disease
- Employee at partner corporation that implemented the study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Planning PromptA prompt to write down a planned date (or date and time) for getting a flu shot | Behavioural | Date Plan Condition, Time Plan Condition |
| Control ConditionA basic reminder mailing prompted each subject to get their flu shot. | Behavioural | Control Condition |
Primary outcome
Receipt of 2009 Seasonal Influenza Vaccination
Time frame: up to 30 weeks
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 22 Sep 2010.
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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.
Katherine L Milkman, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning Prompt in people with Seasonal Influenza, 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 22 Sep 2010. 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?
Receipt of 2009 Seasonal Influenza Vaccination (time frame: up to 30 weeks). 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 22 Sep 2010.