Clinical trial NCT01756001: GlowCaps Adherence Randomized Control Trial
Official title: Using Behavioral Economics to Promote Medication Adherence and Habit Formation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Bureau of Economic Research, Inc.
name: Donaghue Medical Research Foundation
First posted: 2012-12-24
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of doses taken
timeFrame: 40 weeks
Secondary outcomes:
measure: Subjects' reported wellbeing
timeFrame: 13 weeks
measure: Subjects' evaluation of the various interventions
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Judd Kessler
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Dmitry Taubinsky
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Eric Zwick
role: PRINCIPAL_INVESTIGATOR
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