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GlowCaps Adherence Randomized Control Trial

Using Behavioral Economics to Promote Medication Adherence and Habit Formation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01756001
Enrollment
119
Registered
2012-12-24
Start date
2015-02-28
Completion date
2017-03-01
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Adherence

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.

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.

Interventions

DEVICEGlowCap

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.

BEHAVIORALDaily email, text message, or phone call reminders
BEHAVIORALPaid for adherence

Sponsors

Harvard University
CollaboratorOTHER
National Bureau of Economic Research, Inc.
CollaboratorOTHER
Donaghue Medical Research Foundation
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

* patients diagnosed with chronic disease * age 18-84

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of doses taken40 weeksThis 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.

Secondary

MeasureTime frameDescription
Subjects' reported wellbeing13 weeksSecondary 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.
Subjects' evaluation of the various interventions26 weeksSecondary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026