GlowCaps Adherence Randomized Control Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Pennsylvania
Sponsor:
Collaborators:
Harvard University
National Bureau of Economic Research, Inc.
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01756001
First received: December 6, 2012
Last updated: March 14, 2013
Last verified: November 2012
  Purpose

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 5 arms of the experiment. In addition to a control arm, our four arms will be: reminders, feedback and evaluation, reports sent to friends and relatives, and financial incentives.


Condition Intervention
Medical Adherence
Device: GlowCap
Behavioral: Daily email, text message, or phone call reminders
Behavioral: Feedback and evaluation
Behavioral: Feedback provided to friend or family member
Behavioral: Paid for adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Using Behavioral Economics to Promote Medication Adherence and Habit Formation

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Number of doses taken [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Subjects' reported wellbeing [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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.

  • Subjects' evaluation of the various interventions [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: March 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Experimental: 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
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.
Behavioral: Daily email, text message, or phone call reminders
Experimental: Feedback Arm
Arm 3 will be the Feedback arm. Subjects will be told that to aid in daily adherence to the medication, they will be provided with feedback on their adherence for the first three months of the study and possibly again later in the study. Feedback and evaluation will take the form of a weekly email message at 8am on Sunday morning that will inform the subject of the number of days in the preceding week (Sunday to Saturday) that they opened the Vitality pill bottle. This feedback will be accompanied by an evaluation that indicates their success with medication adherence. Taking the pill each of 7 days would be a "Great", missing one day would be a "Good," missing two days would be "Needs improvement" and missing more than two days would be "Needs significant improvement."
Device: 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.
Behavioral: Feedback and evaluation
Experimental: Social Motivation Arm
Arm 4 will be the Social Motivation arm, which will be identical to the Feedback arm except with feedback provided to a friend or family member of the subject. At the start of the study, subjects will be asked to list up to 3 people who care about the subject's medication adherence and might be interested in receiving the weekly feedback. These people would be contacted and asked to participate in the study as a recipient of feedback information. The feedback recipient would be provided with a monetary incentive to complete surveys at the start and end of the study. The identity of the feedback recipient would be told to the subject at the start of the study.
Device: 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.
Behavioral: Feedback provided to friend or family member
Experimental: Financial Incentives Arm
Arm 5 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
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.
Behavioral: Paid for adherence

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 four additional treatments will either: (1) provide the patient with a daily email, text message, or phone call reminder to take the pill; (2) email the patient a weekly summary of his/her performance and an evaluation of performance highlighting the importance of medication adherence; (3) email the patient, as well as patient-selected friends or family members, a weekly summary of his/her performance; or (4) pay patients for each day that they take their pill.

  Eligibility

Ages Eligible for Study:   16 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed with chronic disease
  • age 16-84

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756001

Contacts
Contact: Caroline Carney 215-573-2782 carcar@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Judd Kessler         
Sponsors and Collaborators
University of Pennsylvania
Harvard University
National Bureau of Economic Research, Inc.
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Judd Kessler University of Pennsylvania
Principal Investigator: Dmitry Taubinsky Harvard University
Principal Investigator: Eric Zwick Harvard University
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01756001     History of Changes
Other Study ID Numbers: 816493, 10035604
Study First Received: December 6, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 25, 2014