DiabetesNCT02411032
Fresh Start Experiment
A study testing Reminder, Fresh start and Fresh start framing in people with Diabetes and Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Reminder, Fresh start and Fresh start framing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,323 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2015
- 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
- customers of our insurance company partner
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 are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking).
Read the detailed description
The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking). In this experiment, the investigators will test (a) whether Humana can increase the effectiveness of its messages by sending them to customers around fresh starts moments and (b) whether highlighting a recent fresh start event in Humana's messages can further increase customer engagement.
- Conditions
- Diabetes, Hypertension
- Being tested
- Reminder, Fresh start, Fresh start framing
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderBehavioural
Customer gets mailing that reminds them to take their medication.
Fresh startBehavioural
Customers receive a mailing around a fresh start event: New Year's or birthday
Fresh start framingBehavioural
The fresh start event will be highlighted in the mailings.
| Study group | Role | What they receive |
|---|---|---|
| Reminder control | Experimental | Customers receive a mailing on a random day, which does not coincide with any of the predictable fresh start events. Receives: Behavioral: Reminder |
| Birthday framed | Experimental | Customers receive a mailing on the most recent Wednesday before the customers' birthday, and the mailing frames the customers' birthday by emphasizing a fresh start associated with the customers' birthday. Receives: Behavioral: Fresh start; Behavioral: Fresh start framing |
| New Year's framed | Experimental | Customers receive a mailing on 1/21/15, and the mailing frames the customers' birthday by emphasizing a fresh start associated with the customers' birthday. Receives: Behavioral: Fresh start; Behavioral: Fresh start framing |
| Birthday un-framed | Experimental | Customers receive a mailing on the most recent Wednesday before the customers' birthday, but the mailing does not frame the customers' birthday. Receives: Behavioral: Fresh start |
| New Year's un-framed | Experimental | Customers receive a mailing on 1/21/15, but the mailing does not frame New Year's. Receives: Behavioral: Fresh start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication refills
frequency of refilling medication
Measured: 6 months
Secondary outcomes (2)
Hemoglobin A1C
Measured: 6 months
LDL cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13,323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Milkman, University of Pennsylvania
- Investigators
- Katherine Milkman, Ph.D, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411032
- Sponsor's protocol ID
- 820768
- Status last verified
- May 2017
- First submitted
- 3 Apr 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Start Experiment
- ClinicalTrials.gov ID
- NCT02411032
- Acronym / sponsor ID
- 820768
- Conditions
- Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,323 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Apr 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.
The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking).
Detailed description
The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking). In this experiment, the investigators will test (a) whether Humana can increase the effectiveness of its messages by sending them to customers around fresh starts moments and (b) whether highlighting a recent fresh start event in Humana's messages can further increase customer engagement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Reminder control | Experimental | Behavioral: ReminderCustomers receive a mailing on a random day, which does not coincide with any of the predictable fresh start events. |
| Birthday framed | Experimental | Behavioral: Fresh start, Behavioral: Fresh start framingCustomers receive a mailing on the most recent Wednesday before the customers' birthday, and the mailing frames the customers' birthday by emphasizing a fresh start associated with the customers' birthday. |
| New Year's framed | Experimental | Behavioral: Fresh start, Behavioral: Fresh start framingCustomers receive a mailing on 1/21/15, and the mailing frames the customers' birthday by emphasizing a fresh start associated with the customers' birthday. |
| Birthday un-framed | Experimental | Behavioral: Fresh startCustomers receive a mailing on the most recent Wednesday before the customers' birthday, but the mailing does not frame the customers' birthday. |
| New Year's un-framed | Experimental | Behavioral: Fresh startCustomers receive a mailing on 1/21/15, but the mailing does not frame New Year's. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- customers of our insurance company partner
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 |
|---|---|---|
| ReminderCustomer gets mailing that reminds them to take their medication. | Behavioural | Reminder control |
| Fresh startCustomers receive a mailing around a fresh start event: New Year's or birthday | Behavioural | Birthday framed, Birthday un-framed, New Year's framed, New Year's un-framed |
| Fresh start framingThe fresh start event will be highlighted in the mailings. | Behavioural | Birthday framed, New Year's framed |
Primary outcome
Medication refills
Time frame: 6 months
frequency of refilling medication
2 secondary outcomes
Hemoglobin A1C
Time frame: 6 months
LDL cholesterol
Time frame: 6 months
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 3 May 2017.
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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 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 Reminder, Fresh start and Fresh start framing in people with Diabetes and Hypertension, 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 1 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 3 May 2017. 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?
Medication refills (time frame: 6 months). 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 3 May 2017.