Using Feedback Reports to Improve Medication Adherence

NCT ID: NCT02480530

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-03

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.

Conditions

Coronary Artery Disease; Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Patients will be given educational material on the importance of adherence to statin medications. The GlowCaps device will be set to only record adherence.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Individual Feedback

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.

Group Type: EXPERIMENTAL

Individual Feedback

Intervention Type: BEHAVIORAL

Patient gets feedback reports on adherence weekly.

Feedback Friend

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

Group Type: EXPERIMENTAL

Individual Feedback

Intervention Type: BEHAVIORAL

Patient gets feedback reports on adherence weekly.

Feedback Friend

Intervention Type: BEHAVIORAL

In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

Interventions

Individual Feedback

Patient gets feedback reports on adherence weekly.

Intervention Type: BEHAVIORAL

Feedback Friend

In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corporal Michael J. Crescenz VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashok Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania/Philadelphia VAMC

Judith Long, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Assistant Professor

Locations

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27612487 (View on PubMed)

Other Identifiers

01461

Identifier Type: -

Identifier Source: org_study_id