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

Acute Myocardial Infarction (AMI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890018
• Other study ID #: 817167
• Secondary ID: 1C1CMS331009-01-
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: November 14, 2017
• Start date: June 2013
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient pharmacy benefits-this will be a composite outcome measure assessing MPR	Secondary outcomes will be gap ratios and medication possession ratios.	18 months
Secondary	Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization	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