Medical AdherenceNCT01756001
GlowCaps Adherence Randomized Control Trial
An observational study of Medical Adherence, run by University of Pennsylvania at 1 site in United States.
Trial summary
This randomized control trial will explore interventions to promote medication adherence using a novel electronic device that can track daily pill use. 500 subjects will be randomized into 4 arms of the experiment. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Medical Adherence
- What is being tested?
- GlowCap, Daily email, text message, or phone call reminders and Paid for adherence
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 1 Mar 2017
- Phase
- Observational
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 to 64, receiving coverage from Independence Blue Cross (IBX), and receiving an oral prescription for chronic disease. Subjects were recruited from a base pool of eligible subjects identified by IBX as patients who have been identified as having the lowest medication possession ratios.
Who may be able to join
- patients diagnosed with chronic disease
- age 18-84
Who cannot join
- all patients not meeting inclusion criteria
- people who report that they currently use a day-of-the-week pill bottle
- people for whom AT\&T does not have reliable wireless service for the Glowcap to communicate with the Way To Health platform
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Behavioral Economics to Promote Medication Adherence and Habit Formation
This randomized control trial will explore interventions to promote medication adherence using a novel electronic device that can track daily pill use. 500 subjects will be randomized into 4 arms of the experiment. In addition to a control arm, our three arms will be: reminders, financial incentives, and reminders and financial incentives.
Read the detailed description
The investigators aim to study simple "behavioral economics" interventions that rely on consumer engagement to overcome cognitive and motivational barriers to medication adherence. Our goals are threefold: (1) to analyze which interventions are most effective in promoting medication adherence; (2) to analyze which interventions are most effective in promoting long-term habits that persist even when the interventions are removed; and (3) to understand how various patient characteristics (e.g. age or risk preferences) predict adherence or treatment receptivity. The investigators plan to track daily adherence of patients to a prescribed chronic disease drug using a new technology that electronically monitors when a pill bottle has been opened. In our control condition, patients will be monitored but not be provided with any reminders, adherence information, or incentive to adhere to their medication. Our three additional treatments will be either: (1) provide the patient with a daily email, text message, or phone call reminder to take the pill; (2) pay patients for each day that they take their pill (3) provide the patient with a daily email, text message, or phone call reminder to take the pill and pay patients for each day that they take their pill.
- Conditions
- Medical Adherence
- Being tested
- GlowCap, Daily email, text message, or phone call reminders, Paid for adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlowCapDevice
The main research instrument is an electronic pill bottle called GlowCaps (by Vitality) that has the ability to transmit adherence data to the Way to Health (WTH) web portal. The investigators will measure adherence by counting the number of properly taken doses during the final four weeks of the study. Each time the pill bottle is opened, a date- and time-stamped wireless signal is sent to the Vitality server via the AT\&T cellular network which will then be uploaded to the Way to Health portal for aggregation.
Daily email, text message, or phone call remindersBehavioural
Paid for adherenceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Arm 1 will be the Control arm, in which subjects will be instructed to use the GlowCap for their chronic disease medication but will not be provided with any specific incentive for taking the medication or with any aid in remembering to do so. Receives: Device: GlowCap | |
| Reminder Arm | Arm 2 will be the Reminder arm with daily email, text message, or phone call reminders for intervention. Subjects will be told that to aid in daily adherence to the medication, they will be provided with reminders for the first three months of the study and possibly again later in the study. At the start of the study, subjects will be given the option to receive daily email reminders, text message reminders, or daily (automated) phone call reminders to take their pill, each at a time of day that they choose. The default setting will be for subjects to receive both text and email reminders at 8AM each day. Subjects will be instructed on how to change their settings if they would like to receive a different set of reminders at different points in time. Receives: Device: GlowCap; Behavioral: Daily email, text message, or phone call reminders | |
| Incentives Arm | Arm 3 will be the financial incentives arm, in which subjects will be paid for adherence. Their total earnings will be administered at the end of the experiment through the WTH platform. Receives: Device: GlowCap; Behavioral: Paid for adherence | |
| Incentives and Reminders Arm | Arm 4 will be the financial incentives and reminders arm, in which subjects will be paid for adherence. Their total earnings will be administered at the end of the experiment through the WTH platform. They will also receive daily email, text message, or phone call reminders for intervention. Subjects will be told that to aid in daily adherence to the medication, they will be provided with reminders for the first three months of the study and possibly again later in the study. At the start of the study, subjects will be given the option to receive daily email reminders, text message reminders, or daily (automated) phone call reminders to take their pill, each at a time of day that they choose. The default setting will be for subjects to receive both text and email reminders at 8AM each day. Subjects will be instructed on how to change their settings if they would like to receive a different set of reminders at different points in time. Receives: Device: GlowCap; Behavioral: Daily email, text message, or phone call reminders; Behavioral: Paid for adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of doses taken
This is a randomized controlled study with 5 arms - 1 control and 4 interventional. The primary outcome will be the number of doses taken as directed during the course of the study.
Measured: 40 weeks
Secondary outcomes (2)
Subjects' reported wellbeing
Secondary outcomes will be subjects' reported wellbeing and subjects' evaluations of the various interventions. Secondary outcomes will also include claims and cost of care for subjects from Blue Cross Blue Shield (BCBS) of Massachusetts for two years after the intervention.
Measured: 13 weeks
Subjects' evaluation of the various interventions
Secondary outcomes will be subjects' reported wellbeing and subjects' evaluations of the various interventions. Secondary outcomes will also include claims and cost of care for subjects from Blue Cross Blue Shield (BCBS) of Massachusetts for two years after the intervention.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startFeb 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, National Bureau of Economic Research, Inc., Donaghue Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Judd Kessler, Principal investigator, University of PennsylvaniaDmitry Taubinsky, Principal investigator, Harvard UniversityEric Zwick, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756001
- Sponsor's protocol ID
- 816493
- Other IDs
- 10035604
- Status last verified
- May 2017
- First submitted
- 6 Dec 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers. All data will be de-identified, aggregated, and summarized.
Publications
Acland, D and Levy, M. Habit Formation and Naivete in Gym Attendance: Evidence from a Field Experiment. Mimeo 2010.
Allcott H. Social norms and energy conservation. Journal of Public Economics 2011; 95: 1982-1095.
Cutler DM, Everett W. Thinking outside the pillbox--medication adherence as a priority for health care reform. N Engl J Med. 2010 Apr 29;362(17):1553-5. doi: 10.1056/NEJMp1002305. Epub 2010 Apr 7. No abstract available.
PubMed 20375400Deci, E. Effects of externally mediated rewards on intrinsic motivation. Journal of Personality and Social Psychology 1971; 18: 105-115.
Doshi JA, Zhu J, Lee BY, Kimmel SE, Volpp KG. Impact of a prescription copayment increase on lipid-lowering medication adherence in veterans. Circulation. 2009 Jan 27;119(3):390-7. doi: 10.1161/CIRCULATIONAHA.108.783944. Epub 2009 Jan 12.
PubMed 19139387Gerber AS, Green DP, Larimer CW. Social pressure and voter turnout: evidence from a large- scale field experiment 2008; 102:22-48.
Gneezy U, Rustichini A. Pay enough or don't pay at all. Quarterly Journal of Economics 2000; 115: 791-810.
Gneezy U, Rustichini A. A fine is a price. Journal of legal studies 2000; 29: 1-18.
Karlan D, McConnell M, Mullainathan S, Zinman J. Getting to the top of mind: How reminders increase saving. Mimeo 2010.
Long JA, Helweg-Larsen M, Volpp KG. Patient opinions regarding 'pay for performance for patients'. J Gen Intern Med. 2008 Oct;23(10):1647-52. doi: 10.1007/s11606-008-0739-1. Epub 2008 Jul 29.
PubMed 18663540Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Schultz PW, Nolan JM, Cialdini RB, Goldstein NJ, Griskevicius V. The constructive, destructive, and reconstructive power of social norms. Psychol Sci. 2007 May;18(5):429-34. doi: 10.1111/j.1467-9280.2007.01917.x.
PubMed 17576283Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
PubMed 19066383Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PubMed 19102784
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Economics to Promote Medication Adherence and Habit Formation
- ClinicalTrials.gov ID
- NCT01756001
- Acronym / sponsor ID
- 816493
- Conditions
- Medical Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Harvard University, National Bureau of Economic Research, Inc., Donaghue Medical Research Foundation
- Study start
- Feb 2015
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 24 Dec 2012 (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 randomized control trial will explore interventions to promote medication adherence using a novel electronic device that can track daily pill use. 500 subjects will be randomized into 4 arms of the experiment. In addition to a control arm, our three arms will be: reminders, financial incentives, and reminders and financial incentives.
Detailed description
The investigators aim to study simple "behavioral economics" interventions that rely on consumer engagement to overcome cognitive and motivational barriers to medication adherence. Our goals are threefold: (1) to analyze which interventions are most effective in promoting medication adherence; (2) to analyze which interventions are most effective in promoting long-term habits that persist even when the interventions are removed; and (3) to understand how various patient characteristics (e.g. age or risk preferences) predict adherence or treatment receptivity. The investigators plan to track daily adherence of patients to a prescribed chronic disease drug using a new technology that electronically monitors when a pill bottle has been opened. In our control condition, patients will be monitored but not be provided with any reminders, adherence information, or incentive to adhere to their medication. Our three additional treatments will be either: (1) provide the patient with a daily email, text message, or phone call reminder to take the pill; (2) pay patients for each day that they take their pill (3) provide the patient with a daily email, text message, or phone call reminder to take the pill and pay patients for each day that they take their pill.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | – | Device: GlowCapArm 1 will be the Control arm, in which subjects will be instructed to use the GlowCap for their chronic disease medication but will not be provided with any specific incentive for taking the medication or with any aid in remembering to do so. |
| Reminder Arm | – | Device: GlowCap, Behavioral: Daily email, text message, or phone call remindersArm 2 will be the Reminder arm with daily email, text message, or phone call reminders for intervention. Subjects will be told that to aid in daily adherence to the medication, they will be provided with reminders for the first three months of the study and possibly again later in the study. At the start of the study, subjects will be given the option to receive daily email reminders, text message reminders, or daily (automated) phone call reminders to take their pill, each at a time of day that they choose. The default setting will be for subjects to receive both text and email reminders at 8AM each day. Subjects will be instructed on how to change their settings if they would like to receive a different set of reminders at different points in time. |
| Incentives Arm | – | Device: GlowCap, Behavioral: Paid for adherenceArm 3 will be the financial incentives arm, in which subjects will be paid for adherence. Their total earnings will be administered at the end of the experiment through the WTH platform. |
| Incentives and Reminders Arm | – | Device: GlowCap, Behavioral: Daily email, text message, or phone call reminders, Behavioral: Paid for adherenceArm 4 will be the financial incentives and reminders arm, in which subjects will be paid for adherence. Their total earnings will be administered at the end of the experiment through the WTH platform. They will also receive daily email, text message, or phone call reminders for intervention. Subjects will be told that to aid in daily adherence to the medication, they will be provided with reminders for the first three months of the study and possibly again later in the study. At the start of the study, subjects will be given the option to receive daily email reminders, text message reminders, or daily (automated) phone call reminders to take their pill, each at a time of day that they choose. The default setting will be for subjects to receive both text and email reminders at 8AM each day. Subjects will be instructed on how to change their settings if they would like to receive a different set of reminders at different points in time. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 64, receiving coverage from Independence Blue Cross (IBX), and receiving an oral prescription for chronic disease. Subjects were recruited from a base pool of eligible subjects identified by IBX as patients who have been identified as having the lowest medication possession ratios.
Key inclusion criteria (2 listed)
- patients diagnosed with chronic disease
- age 18-84
Key exclusion criteria (3 listed)
- all patients not meeting inclusion criteria
- people who report that they currently use a day-of-the-week pill bottle
- people for whom AT\&T does not have reliable wireless service for the Glowcap to communicate with the Way To Health platform
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 |
|---|---|---|
| GlowCapThe main research instrument is an electronic pill bottle called GlowCaps (by Vitality) that has the ability to transmit adherence data to the Way to Health (WTH) web portal. The investigators will measure adherence by counting the number of properly taken doses during the final four weeks of the study. Each time the pill bottle is opened, a date- and time-stamped wireless signal is sent to the Vitality server via the AT\&T cellular network which will then be uploaded to the Way to Health portal for aggregation. | Device | Control Arm, Incentives Arm, Incentives and Reminders Arm, Reminder Arm |
| Daily email, text message, or phone call reminders | Behavioural | Incentives and Reminders Arm, Reminder Arm |
| Paid for adherence | Behavioural | Incentives Arm, Incentives and Reminders Arm |
Primary outcome
Number of doses taken
Time frame: 40 weeks
This is a randomized controlled study with 5 arms - 1 control and 4 interventional. The primary outcome will be the number of doses taken as directed during the course of the study.
2 secondary outcomes
Subjects' reported wellbeing
Time frame: 13 weeks
Subjects' evaluation of the various interventions
Time frame: 26 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 9 May 2017.
- BackgroundAcland, D and Levy, M. Habit Formation and Naivete in Gym Attendance: Evidence from a Field Experiment. Mimeo 2010.
- BackgroundAllcott H. Social norms and energy conservation. Journal of Public Economics 2011; 95: 1982-1095.
- Background: PubMed 20375400Cutler DM, Everett W. Thinking outside the pillbox--medication adherence as a priority for health care reform. N Engl J Med. 2010 Apr 29;362(17):1553-5. doi: 10.1056/NEJMp1002305. Epub 2010 Apr 7. No abstract available.
- BackgroundDeci, E. Effects of externally mediated rewards on intrinsic motivation. Journal of Personality and Social Psychology 1971; 18: 105-115.
- Background: PubMed 19139387Doshi JA, Zhu J, Lee BY, Kimmel SE, Volpp KG. Impact of a prescription copayment increase on lipid-lowering medication adherence in veterans. Circulation. 2009 Jan 27;119(3):390-7. doi: 10.1161/CIRCULATIONAHA.108.783944. Epub 2009 Jan 12.
- BackgroundGerber AS, Green DP, Larimer CW. Social pressure and voter turnout: evidence from a large- scale field experiment 2008; 102:22-48.
- BackgroundGneezy U, Rustichini A. Pay enough or don't pay at all. Quarterly Journal of Economics 2000; 115: 791-810.
- BackgroundGneezy U, Rustichini A. A fine is a price. Journal of legal studies 2000; 29: 1-18.
- BackgroundKarlan D, McConnell M, Mullainathan S, Zinman J. Getting to the top of mind: How reminders increase saving. Mimeo 2010.
- Background: PubMed 18663540Long JA, Helweg-Larsen M, Volpp KG. Patient opinions regarding 'pay for performance for patients'. J Gen Intern Med. 2008 Oct;23(10):1647-52. doi: 10.1007/s11606-008-0739-1. Epub 2008 Jul 29.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 17576283Schultz PW, Nolan JM, Cialdini RB, Goldstein NJ, Griskevicius V. The constructive, destructive, and reconstructive power of social norms. Psychol Sci. 2007 May;18(5):429-34. doi: 10.1111/j.1467-9280.2007.01917.x.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers. All data will be de-identified, aggregated, and summarized.
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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.
Judd Kessler principal investigator
University of Pennsylvania
Dmitry Taubinsky principal investigator
Harvard University
Eric Zwick principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical 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 2 inclusion and 3 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 9 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?
Number of doses taken (time frame: 40 weeks). 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 NCT01756001, which also lists 14 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 9 May 2017.