GlowCaps Adherence Randomized Control Trial

NCT ID: NCT01756001

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-03-01

Brief Summary

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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

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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

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Medical Adherence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

GlowCap

Intervention Type DEVICE

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.

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.

GlowCap

Intervention Type DEVICE

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 reminders

Intervention Type BEHAVIORAL

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.

GlowCap

Intervention Type DEVICE

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.

Paid for adherence

Intervention Type BEHAVIORAL

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.

GlowCap

Intervention Type DEVICE

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 reminders

Intervention Type BEHAVIORAL

Paid for adherence

Intervention Type BEHAVIORAL

Interventions

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GlowCap

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.

Intervention Type DEVICE

Daily email, text message, or phone call reminders

Intervention Type BEHAVIORAL

Paid for adherence

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with chronic disease
* age 18-84

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

National Bureau of Economic Research, Inc.

OTHER

Sponsor Role collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judd Kessler

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Dmitry Taubinsky

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Eric Zwick

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Acland, D and Levy, M. Habit Formation and Naivete in Gym Attendance: Evidence from a Field Experiment. Mimeo 2010.

Reference Type BACKGROUND

Allcott H. Social norms and energy conservation. Journal of Public Economics 2011; 95: 1982-1095.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20375400 (View on PubMed)

Deci, E. Effects of externally mediated rewards on intrinsic motivation. Journal of Personality and Social Psychology 1971; 18: 105-115.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19139387 (View on PubMed)

Gerber AS, Green DP, Larimer CW. Social pressure and voter turnout: evidence from a large- scale field experiment 2008; 102:22-48.

Reference Type BACKGROUND

Gneezy U, Rustichini A. Pay enough or don't pay at all. Quarterly Journal of Economics 2000; 115: 791-810.

Reference Type BACKGROUND

Gneezy U, Rustichini A. A fine is a price. Journal of legal studies 2000; 29: 1-18.

Reference Type BACKGROUND

Karlan D, McConnell M, Mullainathan S, Zinman J. Getting to the top of mind: How reminders increase saving. Mimeo 2010.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 18663540 (View on PubMed)

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

Reference Type BACKGROUND
PMID: 16079372 (View on PubMed)

Schultz 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.

Reference Type BACKGROUND
PMID: 17576283 (View on PubMed)

Volpp 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.

Reference Type BACKGROUND
PMID: 19066383 (View on PubMed)

Volpp 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.

Reference Type BACKGROUND
PMID: 19102784 (View on PubMed)

Other Identifiers

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10035604

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

816493

Identifier Type: -

Identifier Source: org_study_id

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