AdherenceNCT02354729
Encouraging Allergic Young Adults to Carry Epinephrine
A study testing Behavioral Economics in people with Adherence and Food Allergy, run by University of Pennsylvania.
Trial summary
Fifteen million Americans suffer from food allergies. Food allergies can be life threatening; the only known life-saving treatment is epinephrine. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Food Allergy
- What is being tested?
- Behavioral Economics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have known food allergy
- Epinephrine auto-injector prescription
- Access to a cell phone with ability to send picture messages
Who cannot join
- -
About this study
Official title: Using Text Messaging and Financial Incentives to Encourage Allergic Young Adults to Carry Epinephrine
Fifteen million Americans suffer from food allergies. Food allergies can be life threatening; the only known life-saving treatment is epinephrine. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine. This is a pilot randomized trial to test text message reminders, with and without financial incentives, to encourage allergic young adults to carry epinephrine.
Read the detailed description
Aim: We pilot tested a novel strategy to encourage young adults with food allergies to carry their epinephrine auto-injectors. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine.
Study design: This is a pilot randomized controlled trial, with a survey component. Text messaging is the mode of communication and inquiry with study participants.
Hypothesis: The intervention group, which will receive modest financial incentives for carrying epinephrine, will be more likely to demonstrate that they are carrying their epinephrine, when queried by the study team.
This study employs text messaging, along with photography, as a mode of momentary ecologic assessment, or real-time measurement of epinephrine carrying. In addition, text messaging was used as a mode of asking questions regarding food allergy knowledge and beliefs among young adults. Text messages were sent from a designated telephone (and telephone number) purchased for use in this study. We used text messaging for reminder messages, text responses, and for the participants to send photographs back to us. We converted text message data (participants responses) into a RedCap database. Our research coordinator sent and received the text messages and compiled a secure RedCap database of responses.
- Conditions
- Adherence, Food Allergy
- Being tested
- Behavioral Economics
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral EconomicsOther
Use financial incentives to promote epinephrine-carrying.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants received text messages and financial incentives after successfully documenting that they were carrying their epinephrine auto-injectors, based on principles of behavioral economics. Receives: Other: Behavioral Economics |
| Control | No intervention | Participants received text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of check-ins at which participant is carrying epinephrine
Proportion of check-ins at which participants were successfully carrying their epinephrine, measured using cell phone photographs.
Measured: 10 randomly timed check-ins during the 7 week intervention period
Secondary outcomes (1)
Self-reported acceptability of text messages
Assess young adults' perspectives on text messaging as a vehicle for communicating health messages.
Measured: Measured at the end of the 7 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Cannuscio, University of Pennsylvania
- Investigators
- Carolyn C Cannuscio, ScD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354729
- Sponsor's protocol ID
- UPenn
- Status last verified
- Jun 2018
- First submitted
- 23 Jan 2015
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cannuscio CC, Dupuis R, Graves A, Seymour JW, Kounaves S, Strupp E, Leri D, Frasso R, Grande D, Meisel ZF. A behavioral economics intervention to encourage epinephrine-carrying among food-allergic adults: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Sep;115(3):234-240.e1. doi: 10.1016/j.anai.2015.05.018. Epub 2015 Jun 17.
PubMed 26093776
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Text Messaging and Financial Incentives to Encourage Allergic Young Adults to Carry Epinephrine
- ClinicalTrials.gov ID
- NCT02354729
- Acronym / sponsor ID
- UPenn
- Conditions
- Adherence, Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Feb 2015 (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.
Fifteen million Americans suffer from food allergies. Food allergies can be life threatening; the only known life-saving treatment is epinephrine. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine. This is a pilot randomized trial to test text message reminders, with and without financial incentives, to encourage allergic young adults to carry epinephrine.
Detailed description
Aim: We pilot tested a novel strategy to encourage young adults with food allergies to carry their epinephrine auto-injectors. Adolescents/young adults are at increased risk of adverse events, because of increased risk-taking with food and decreased likelihood of carrying epinephrine.
Study design: This is a pilot randomized controlled trial, with a survey component. Text messaging is the mode of communication and inquiry with study participants.
Hypothesis: The intervention group, which will receive modest financial incentives for carrying epinephrine, will be more likely to demonstrate that they are carrying their epinephrine, when queried by the study team.
This study employs text messaging, along with photography, as a mode of momentary ecologic assessment, or real-time measurement of epinephrine carrying. In addition, text messaging was used as a mode of asking questions regarding food allergy knowledge and beliefs among young adults. Text messages were sent from a designated telephone (and telephone number) purchased for use in this study. We used text messaging for reminder messages, text responses, and for the participants to send photographs back to us. We converted text message data (participants responses) into a RedCap database. Our research coordinator sent and received the text messages and compiled a secure RedCap database of responses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Behavioral EconomicsParticipants received text messages and financial incentives after successfully documenting that they were carrying their epinephrine auto-injectors, based on principles of behavioral economics. |
| Control | No intervention | –Participants received text messages. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have known food allergy
- Epinephrine auto-injector prescription
- Access to a cell phone with ability to send picture messages
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 |
|---|---|---|
| Behavioral EconomicsUse financial incentives to promote epinephrine-carrying. | Other | Intervention |
Primary outcome
Proportion of check-ins at which participant is carrying epinephrine
Time frame: 10 randomly timed check-ins during the 7 week intervention period
Proportion of check-ins at which participants were successfully carrying their epinephrine, measured using cell phone photographs.
1 secondary outcome
Self-reported acceptability of text messages
Time frame: Measured at the end of the 7 week intervention
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 Jun 2018.
- Results publication: PubMed 26093776Cannuscio CC, Dupuis R, Graves A, Seymour JW, Kounaves S, Strupp E, Leri D, Frasso R, Grande D, Meisel ZF. A behavioral economics intervention to encourage epinephrine-carrying among food-allergic adults: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Sep;115(3):234-240.e1. doi: 10.1016/j.anai.2015.05.018. Epub 2015 Jun 17.
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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.
Carolyn C Cannuscio, ScD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Economics in people with Adherence and Food Allergy, run by University of Pennsylvania.
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 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of check-ins at which participant is carrying epinephrine (time frame: 10 randomly timed check-ins during the 7 week intervention period). 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 NCT02354729, 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 15 Jun 2018.