NCT01890018

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

May 9, 2013

Last Update Submit

November 14, 2017

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction (AMI)taking a statin medicationalso have a medication adherence ratio (MPR)

Outcome Measures

Primary Outcomes (1)

  • Glowcap bottle openings/Medication Adherence

    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 Outcomes (2)

  • Patient pharmacy benefits-this will be a composite outcome measure assessing MPR

    18 months

  • Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization

    18 months

Study Arms (4)

Control

ACTIVE COMPARATOR

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

Feedback group

EXPERIMENTAL

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 trackingBehavioral: Adherence Messaging

Adherence partner group

EXPERIMENTAL

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 trackingBehavioral: Social Influence

Adherence partner along with feedback

EXPERIMENTAL

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 trackingBehavioral: Adherence MessagingBehavioral: Social Influence

Interventions

Electronic Pill Bottle trackingBEHAVIORAL

All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications

Adherence partner along with feedbackAdherence partner groupControlFeedback group
Adherence MessagingBEHAVIORAL

Some arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days.

Adherence partner along with feedbackFeedback group
Social InfluenceBEHAVIORAL

Some arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled.

Adherence partner along with feedbackAdherence partner group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

    PMID: 33769555DERIVED

  • Kessler JB, Troxel AB, Asch DA, Mehta SJ, Marcus N, Lim R, Zhu J, Shrank W, Brennan T, Volpp KG. Partners and Alerts in Medication Adherence: A Randomized Clinical Trial. J Gen Intern Med. 2018 Sep;33(9):1536-1542. doi: 10.1007/s11606-018-4389-7. Epub 2018 Mar 15.

    PMID: 29546659DERIVED

Study Officials

  • Judd B Kessler, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

July 1, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

August 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(1)