Partners and Alerts: A Study of Social Forces in Medication Adherence

November 14, 2017 updated by: University of Pennsylvania

The overall objectives of this study are to improve medication adherence of patients and subsequent health outcomes.

This study is designed to examine the existence of strong associations between social networks and health behavior. This study intends to demonstrate that social forces are particularly effective at building enduring habits for healthy behavior, specifically adherence to statin medication for this study. The investigators believe the improved medication adherence will result in fewer additional vascular events, following the most recent of these events, and will result in fewer patient hospitalizations. The investigators will leverage insights from the fields of social comparison (being provided with information about the actions of others prompts social comparison that can significantly influence behavior), social pressures (encouragement or discouragement from others is a powerful social force that can influence individual behavior), and social triggers (cues in the environment can motivate people to take certain actions and have powerful effects on purchasing behavior).

The results of this study and experience gained from the implementation of these interventions will be used to inform new versions of a larger trial intervention to be tested in new patient cohorts in a rapid cycle framework.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a 4-arm pilot study involving 248 patients (62 per arm) who are on a once-a-day statin who have a medication adherence ratio (MPR) that is less than 80%. Patients in all arms would receive a GlowCap, manufactured by Vitality Inc., which records pill-bottle openings and be asked to use the GlowCap for that medication for the duration of the study.

The study arms leverage two strategies that the investigators think will be particularly effective at improving adherence and may be even more effective when used in tandem. Patients in some arms will be asked to select an adherence partner: another person who can help them adhere to their medication regimen. The investigators will contact this adherence partner and ask them to officially accept this role and provide guidance of their choosing as to how they can help the patient adhere. In addition, patients in some arms will receive an alert whenever two full days pass without their GlowCap being opened (i.e. 48 hours of non-adherence). This alert will encourage them to begin taking their medication again. The design allows for some patients to have both an adherence partner and to receive alerts after 48 hours of non-adherence. In these arms, the adherence partner would also receive the alert after 48 hours of non-adherence. This introduces a two-by-two design.

Subjects would spend 6 months in their randomly assigned treatment, and the investigators will compare adherence of subjects in each of the arms to one another.

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 inclusion of friend of family member to help them adhere to their medication. Our four additional treatments will either: (1) email the patient after 48 hours of non-adherence; (2) allow the patient to select friend or family member to encourage medication adherence; (3) email the patient, as well as patient-selected friends or family members after 48 hours of non-adherence; or (4) provide the patient with a daily email, text message, or phone call reminder to take the pill.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients must have

  • experienced an AMI and have been placed on a once-a-day statin and have a medication adherence ratio (MPR) that is less than 80%.
  • access to internet to create an account on Way to Heath.

Exclusion Criteria:

  • There are no exclusion criterial for patients able to provide consent and who meet the eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control

This arm will use GlowCaps to have their adherence tracked with no additional modifications:

Arm 1. Control group no modifications

Electronic Pill Bottle tracking
Behavioral: Electronic Pill Bottle tracking
All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
EXPERIMENTAL: Feedback group

This arm will use GlowCaps to have their adherence tracked with the following modifications:

Arm 2. Feedback group participants will receive an adherence message after 48 hours of not using the GlowCaps

Electronic Pill Bottle tracking; Adherence Messaging
Behavioral: Electronic Pill Bottle tracking
All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
Behavioral: Adherence Messaging
Some arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days.
EXPERIMENTAL: Adherence partner group

This arm will use GlowCaps to have their adherence tracked with the following modifications:

Arm 3. Adherence partner group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient

Electronic Pill Bottle tracking; Social Influence
Behavioral: Electronic Pill Bottle tracking
All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
Behavioral: Social Influence
Some arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled.
EXPERIMENTAL: Adherence partner along with feedback

This arm will use GlowCaps to have their adherence tracked with the following modifications:

Arm 4. Adherence partner along with feedback group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient, both the patient and partner will receive a message after 48 hours of not using the GlowCaps

Electronic Pill Bottle tracking; Adherence Messaging; Social Influence
Behavioral: Electronic Pill Bottle tracking
All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
Behavioral: Adherence Messaging
Some arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days.
Behavioral: Social Influence
Some arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glowcap bottle openings/Medication Adherence
Time Frame: 6 months
Primary outcome will measure the the number of days the GlowCap pill bottle is opened at least 1 time over the 6 month enrollment period, to be measured at 6 months after enrollment for each participant. Medication adherence for this study is considered to be at least 1 registered GlowCap opening for each day enrolled on the study. (N days at least 1 opening/180 days = Medication Adherence %)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient pharmacy benefits-this will be a composite outcome measure assessing MPR
Time Frame: 18 months
Secondary outcomes will be gap ratios and medication possession ratios.
18 months
Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization
Time Frame: 18 months
Secondary outcomes will be the number of repeat vascular events, following a similar approach to MI-FREEE, hospitalization, repeat or new cardiovascular procedures, and cost.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Judd B Kessler, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

July 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817167
  • 1C1CMS331009-01-00 (Other Grant/Funding Number: Center for Medicare & Medicaid Innovation (CMMI))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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