Clinical trial NCT02480530: Using Feedback Reports to Improve Medication Adherence
Official title: Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Adherence
Keywords: Medication Adherence
Reciprocal Peer
Telemonitoring
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2015-06-24
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: Change in baseline adherence at 3 month and 6 month
Secondary outcomes:
measure: Patient Activation
timeFrame: Change in baseline patient activation at 3 month and 6 month
measure: Social Support
timeFrame: Change in baseline social support at 3 month and 6 month
measure: LDL levels
timeFrame: Change in baseline LDL level at 6 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania/Philadelphia VAMC
name: Ashok Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania Assistant Professor
name: Judith Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reddy A, Huseman TL, Canamucio A, Marcus SC, Asch DA, Volpp K, Long JA. Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial. J Gen Intern Med. 2017 Mar;32(3):256-261. doi: 10.1007/s11606-016-3858-0. Epub 2016 Sep 9.