DiabetesNCT02086539
Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study
A study testing Large Envelope, Priority Mail and Amazon in people with Diabetes, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Large Envelope, Priority Mail and Amazon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 23 Jul 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes and or history of CVD
- LDL > or = 130 mg/dl - measured during screening
- A prescription filled for statin medication within the last 12 months
- Medication Possession Ratio (MPR) <80%
- CVS Caremark Beneficiary
Who cannot join
- Less than 18 years old
- Contraindication to further statin use or have suffered side effects from statins, such as myopathy
- Will not or cannot give consent
- History of active or progressive liver disease or abnormal liver function tests on baseline screening
- Currently participating in another clinical trial with related aims
- Co-morbidities likely to lead to death within a short-period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study
This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.
- Conditions
- Diabetes
- Being tested
- Large Envelope, Priority Mail, Amazon
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large EnvelopeOther
Priority MailOther
AmazonOther
| Study group | Role | What they receive |
|---|---|---|
| Normal Letter | No intervention | This arm will receive the recruitment letter in a business sized envelope. The letter states the participant will receive a $25 check upon enrollment into the study. |
| Large Envelope | Experimental | This arm will receive the recruitment letter in an 8.5 x 11 inch envelope. The letter states the participant will receive a $25 check upon enrollment into the study. Receives: Other: Large Envelope |
| Priority Mail | Experimental | Group 3 will receive a recruitment letter shipped via USPS priority mail. The letter states the participant will receive a $25 check upon enrollment into the study. Receives: Other: Priority Mail |
| Amazon | Experimental | This arm will receive a recruitment letter with the image of an Amazon gift card and told they will receive the $25 gift card if they enroll in the study. Receives: Other: Amazon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment into the Habit Formation study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion23 Jul 2016
- Study completion23 Jul 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kevin G Volpp, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086539
- Sponsor's protocol ID
- 816003
- Other IDs
- 5R01AG043844-02
- Status last verified
- Jun 2017
- First submitted
- 11 Mar 2014
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study
- ClinicalTrials.gov ID
- NCT02086539
- Acronym / sponsor ID
- 816003
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Rutgers University, National Institute on Aging (NIA)
- Study start
- Apr 2014
- Primary completion
- 23 Jul 2016 (actual)
- Study completion
- 23 Jul 2016 (actual)
- First posted
- 13 Mar 2014 (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.
This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Letter | No intervention | –This arm will receive the recruitment letter in a business sized envelope. The letter states the participant will receive a $25 check upon enrollment into the study. |
| Large Envelope | Experimental | Other: Large EnvelopeThis arm will receive the recruitment letter in an 8.5 x 11 inch envelope. The letter states the participant will receive a $25 check upon enrollment into the study. |
| Priority Mail | Experimental | Other: Priority MailGroup 3 will receive a recruitment letter shipped via USPS priority mail. The letter states the participant will receive a $25 check upon enrollment into the study. |
| Amazon | Experimental | Other: AmazonThis arm will receive a recruitment letter with the image of an Amazon gift card and told they will receive the $25 gift card if they enroll in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes and or history of CVD
- LDL > or = 130 mg/dl - measured during screening
- A prescription filled for statin medication within the last 12 months
- Medication Possession Ratio (MPR) <80%
- CVS Caremark Beneficiary
Key exclusion criteria (6 listed)
- Less than 18 years old
- Contraindication to further statin use or have suffered side effects from statins, such as myopathy
- Will not or cannot give consent
- History of active or progressive liver disease or abnormal liver function tests on baseline screening
- Currently participating in another clinical trial with related aims
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 |
|---|---|---|
| Large Envelope | Other | Large Envelope |
| Priority Mail | Other | Priority Mail |
| Amazon | Other | Amazon |
Primary outcome
Enrollment into the Habit Formation study
Time frame: 3 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 27 Jun 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.
Kevin G Volpp, MD, PhD 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 Large Envelope, Priority Mail and Amazon in people with Diabetes, 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 5 inclusion and 6 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 27 Jun 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?
Enrollment into the Habit Formation study (time frame: 3 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 27 Jun 2017.