Overview

This trial is active, not recruiting.

Conditions coronary artery disease, adherence
Treatments individual feedback, feedback friend
Sponsor Corporal Michael J. Crescenz VA Medical Center
Start date January 2014
End date October 2017
Trial size 224 participants
Trial identifier NCT02480530, 01461

Summary

The purpose of this research study is to improve statin medication adherence among Veterans with coronary artery disease with poor adherence to medications. The investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication taking behavior.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(No Intervention)
Patients will be given educational material on the importance of adherence to statin medications. The GlowCaps device will be set to only record adherence.
(Experimental)
In addition to educational material on adherence to statin medications, the research coordinator will review set-up of personal reminders for the GlowCaps device which will be set to glow and buzz when the medication is missed. In addition, patients will receive information on the weekly adherence feedback report.
individual feedback
Patient gets feedback reports on adherence weekly.
(Experimental)
The patient will be given educational material on the importance of adhering to statin medications. The research coordinator will review set-up of alarm features of GlowCaps device. Similar to Arm 2, patients will be given information on interpretation of weekly adherence feedback report. If the patient chooses a family/friend, they will be called and provided information on the interpretation of weekly adherence feedback report. If the patient chooses a reciprocal partner, they will be assigned to another patient who has made a similar choice
individual feedback
Patient gets feedback reports on adherence weekly.
feedback friend
In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

Primary Outcomes

Measure
Adherence
time frame: Change in baseline adherence at 3 month and 6 month

Secondary Outcomes

Measure
Patient Activation
time frame: Change in baseline patient activation at 3 month and 6 month
Social Support
time frame: Change in baseline social support at 3 month and 6 month
LDL levels
time frame: Change in baseline LDL level at 6 month

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

Inclusion Criteria: - All participants will have a diagnosis of CAD - To be eligible they must be between the ages of 30-75 years of age-to ensure we are targeting those most likely to benefit from improving control to these medications - Patients must have been prescribed a statin by their provider and a documented poor adherence as measured by a 16-month medication adherence rate (Medication Possession Ratio) of <80% Exclusion Criteria: - Due to the use of the medication adherence reminder device, patients must speak English - Have a home address - Telephone number - Be willing and able to identify a friend or family member - The investigators will exclude atients with active substance abuse, significant hearing loss, or reduced cognitive ability as determined from the patient's problem list

Additional Information

Official title Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease
Principal investigator Ashok Reddy, MD
Description Patients with coronary artery disease and previous poor adherence to statin medications will be recruited at Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to one of three arms: 1. Control Group 2. Individual Alarm device and feedback report 3. Individual plus patient-selected Feedback Friend report Patients will be given a medication-monitoring device (Vitality GlowCaps) to monitor the statin medication that is being currently prescribed by their primary care physician. In first group, the control arm (Arm 1), the device reminders will be turned off but the device will continue recording adherence to the medications. In second group, reminder arm (Arm 2), the device will be programmed as an alarm that will be activated if the patient does not take the medication at the time set by the patient. In addition the patient will get a weekly report of his/her adherence. In the third group, patient-selected family/friend/or reciprocal peer feedback arm (Arm 3), in addition to the activation of the alarm function the device will be linked to a weekly report on adherence to medications. This report will be delivered to the patient and to the patient identified family/friend/ or reciprocal peer.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center.