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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01890018
First received: May 9, 2013
Last updated: December 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction (AMI)
Behavioral: Electronic Pill Bottle tracking
Behavioral: Adherence Messaging
Behavioral: Social Influence
Behavioral: Medication schedule alarms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Partners and Alerts: A Study of Social Forces in Medication Adherence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Glowcap bottle openings/Medication Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 %)


Secondary Outcome Measures:
  • Patient pharmacy benefits-this will be a composite outcome measure assessing MPR [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Secondary outcomes will be gap ratios and medication possession ratios.

  • Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 310
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 5 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 5 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 5 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 5 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.
Experimental: Daily reminders

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

Arm 5. Adherence partner along with feedback and daily reminders 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, and the patient will receive daily reminders through the GlowCap to take their medication.

Electronic Pill Bottle tracking; Medication schedule alarms

Behavioral: Electronic Pill Bottle tracking
All 5 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
Behavioral: Medication schedule alarms
1 arm will have the visual and audial reminder alerts activated on the Glowcaps to alarm when scheduled to take their statin medication.

Detailed Description:

This study is a 5-arm pilot study involving 310 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. Our final arm would also turn on the (audial and visual) reminder functionality of the Vitality GlowCap for patients who have an adherence partner and alerts to look for an interaction between these arms and assistance in remembering to take the medication.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01890018

Contacts
Contact: Christopher W. Meussner, BS 215-573-4934 christopher.meussner@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Chris W. Meussner, BS    215-573-4934    Christopher.Meussner@uphs.upenn.edu   
Contact: Laurie Norton, MA    215-615-0168    Laurie.Norton@uphs.upenn.edu   
Principal Investigator: Judd Kessler, PhD         
Sub-Investigator: Kevin Volpp, MD, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Judd B Kessler, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01890018     History of Changes
Other Study ID Numbers: 817167, 1C1CMS331009-01-00
Study First Received: May 9, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Acute Myocardial Infarction (AMI)
taking a statin medication
also have a medication adherence ratio (MPR)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014