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Completed

NCT Number: NCT01756001

GlowCaps Adherence Randomized Control Trial

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.

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Key information

Conditions

Medical Adherence

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Daily email, text message, or phone call reminders

Behavioral

Paid for adherence

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subjects' reported wellbeing

    Time frame: 13 weeks

    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.

  2. Subjects' evaluation of the various interventions

    Time frame: 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Donaghue Medical Research Foundation
  • Harvard University
  • National Bureau of Economic Research, Inc.

Registry information

Official study title

Using Behavioral Economics to Promote Medication Adherence and Habit Formation

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.