GlowCaps Adherence Randomized Control Trial

NCT01756001 | Completed

• 2 other identifiers: 81649310035604
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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. In addition to a control arm, our three arms will be: reminders, financial incentives, and reminders and financial incentives.

Conditions

Medical Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  40 weeks

Secondary Outcomes (2)

• Subjects' reported wellbeing

  13 weeks

• Subjects' evaluation of the various interventions

  26 weeks

Study Arms (4)

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.

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.

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.

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.

Device: GlowCap; Behavioral: Daily email, text message, or phone call reminders; Behavioral: Paid for adherence

Interventions

GlowCap 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.

Control Arm; Incentives Arm; Incentives and Reminders Arm; Reminder Arm

Daily email, text message, or phone call reminders BEHAVIORAL

Incentives and Reminders Arm; Reminder Arm

Paid for adherence BEHAVIORAL

Incentives Arm; Incentives and Reminders Arm

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• patients diagnosed with chronic disease
• age 18-84

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Harvard University: collaborator
• National Bureau of Economic Research, Inc.: collaborator
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (14)

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

  BACKGROUND

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

  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.

  PMID: 20375400 BACKGROUND

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

  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.

  PMID: 19139387 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 18663540 BACKGROUND

• 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.

  PMID: 16079372 BACKGROUND

• 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.

  PMID: 17576283 BACKGROUND

• 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.

  PMID: 19066383 BACKGROUND

• 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.

  PMID: 19102784 BACKGROUND

MeSH Terms

Interventions

Compensation and Redress

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Jurisprudence; Social Control, Formal

Study Officials

• Judd Kessler

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Dmitry Taubinsky

  Harvard University

  PRINCIPAL INVESTIGATOR

• Eric Zwick

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 24, 2012
• Study Start: February 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)