Medication AdherenceNCT01798784
Habit Formation for Adherence to Statin Use and LDL Reduction
A study testing Sweepstake Incentive 1, Sweepstake Incentive 2 and Sweepstake Incentive 3 in people with Medication Adherence, run by University of Pennsylvania at 1 site in United States.
Trial summary
In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Sweepstake Incentive 1, Sweepstake Incentive 2 and Sweepstake Incentive 3
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2017
- 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
- Individuals at high risk of a cardiac event, specifically one of the following:
- Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
- Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
- Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%;
- Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
- Medication Possession Ratio (MPR) less than or equal to 80%
- Low medication adherence on self-report completed during enrollment
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 when applicable
- 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: Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).
- Conditions
- Medication Adherence
- Being tested
- Sweepstake Incentive 1, Sweepstake Incentive 2, Sweepstake Incentive 3
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweepstake Incentive 1Behavioural
Daily sweepstake conditional on daily medication adherence
Sweepstake Incentive 2Behavioural
Daily sweepstake conditional on daily medication adherence
Sweepstake Incentive 3Behavioural
Daily sweepstake conditional on daily medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes. |
| Sweepstakes Incentive 1 | Experimental | Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication. Receives: Behavioral: Sweepstake Incentive 1 |
| Sweepstake Incentive 2 | Experimental | Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder. Receives: Behavioral: Sweepstake Incentive 2 |
| Sweepstake Incentive 3 | Experimental | Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study. Receives: Behavioral: Sweepstake Incentive 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL from baseline to 12 months
Measured: 12 months
Secondary outcomes (1)
Statin Adherence 6 months after active phase of intervention
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 posted26 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University, Rutgers University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kevin Volpp, MD, PhD, Principal investigator, University of PennsylvaniaIwan Barankay, PhD, Principal investigator, University of PennsylvaniaPeter Reese, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798784
- Sponsor's protocol ID
- 1R01AG043844-01
- Other IDs
- 5R01AG043844
- Status last verified
- May 2020
- First submitted
- 21 Feb 2013
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barankay I, Reese PP, Putt ME, Russell LB, Phillips C, Pagnotti D, Chadha S, Oyekanmi KO, Yan J, Zhu J, Volpp KG, Clapp JT. Qualitative Exploration of Barriers to Statin Adherence and Lipid Control: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e219211. doi: 10.1001/jamanetworkopen.2021.9211.
PubMed 33944923Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20.
PubMed 33218296Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429.
PubMed 33034639Putt ME, Reese PP, Volpp KG, Russell LB, Loewenstein G, Yan J, Pagnotti D, McGilloway R, Brennen T, Finnerty D, Hoffer K, Chadha S, Barankay I. The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies. Clin Trials. 2019 Aug;16(4):399-409. doi: 10.1177/1740774519846852. Epub 2019 May 31.
PubMed 31148473
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
- ClinicalTrials.gov ID
- NCT01798784
- Acronym / sponsor ID
- 1R01AG043844-01
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Carnegie Mellon University, Rutgers University, National Institute on Aging (NIA)
- Study start
- Jul 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Feb 2013 (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.
In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes. |
| Sweepstakes Incentive 1 | Experimental | Behavioral: Sweepstake Incentive 1Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication. |
| Sweepstake Incentive 2 | Experimental | Behavioral: Sweepstake Incentive 2Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder. |
| Sweepstake Incentive 3 | Experimental | Behavioral: Sweepstake Incentive 3Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals at high risk of a cardiac event, specifically one of the following:
- Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
- Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
- Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%;
- Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
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 when applicable
- 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 |
|---|---|---|
| Sweepstake Incentive 1Daily sweepstake conditional on daily medication adherence | Behavioural | Sweepstakes Incentive 1 |
| Sweepstake Incentive 2Daily sweepstake conditional on daily medication adherence | Behavioural | Sweepstake Incentive 2 |
| Sweepstake Incentive 3Daily sweepstake conditional on daily medication adherence | Behavioural | Sweepstake Incentive 3 |
Primary outcome
Change in LDL from baseline to 12 months
Time frame: 12 months
1 secondary outcome
Statin Adherence 6 months after active phase of intervention
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 20 May 2020.
- Derived from this study: PubMed 33944923Barankay I, Reese PP, Putt ME, Russell LB, Phillips C, Pagnotti D, Chadha S, Oyekanmi KO, Yan J, Zhu J, Volpp KG, Clapp JT. Qualitative Exploration of Barriers to Statin Adherence and Lipid Control: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e219211. doi: 10.1001/jamanetworkopen.2021.9211.
- Derived from this study: PubMed 33218296Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20.
- Derived from this study: PubMed 33034639Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429.
- Derived from this study: PubMed 31148473Putt ME, Reese PP, Volpp KG, Russell LB, Loewenstein G, Yan J, Pagnotti D, McGilloway R, Brennen T, Finnerty D, Hoffer K, Chadha S, Barankay I. The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies. Clin Trials. 2019 Aug;16(4):399-409. doi: 10.1177/1740774519846852. Epub 2019 May 31.
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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 Volpp, MD, PhD principal investigator
University of Pennsylvania
Iwan Barankay, PhD principal investigator
University of Pennsylvania
Peter Reese, MD, MSCE 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 Sweepstake Incentive 1, Sweepstake Incentive 2 and Sweepstake Incentive 3 in people with Medication Adherence, 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 7 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 20 May 2020. 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?
Change in LDL from baseline to 12 months (time frame: 12 months). 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 NCT01798784, which also lists 4 linked publications.
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 20 May 2020.