Using Feedback Reports to Improve Medication Adherence

January 26, 2018 updated by: Corporal Michael J. Crescenz VA Medical Center

Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Individual Feedback
Patient gets feedback reports on adherence weekly.
Experimental: 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
Behavioral: Individual Feedback
Patient gets feedback reports on adherence weekly.
Behavioral: Feedback Friend
In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Change in baseline adherence at 3 month and 6 month
Adherence will be measured using the following formula: [Number of times the pill bottle was opened/(Number of times a day each medication is prescribed to be taken multiplied by the total number of days in study)].
Change in baseline adherence at 3 month and 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation
Time Frame: Change in baseline patient activation at 3 month and 6 month
The investigators will utilize the 13-item Patient Activation Measure (PAM) to measure an individual's activation level.18 This tool has been used in previous studies to predict self-efficacy for health behaviors, such as exercise and medications adherence. Response categories for each item are strongly agree, agree, disagree and strongly disagree. Responses are then scaled and transformed to a score ranging from 0 to 100. These scores are correlated with four stages of activation.
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
The multidimensional scale of perceived social support will be given at baseline, 3-months, and 6-months. This is a 12-item questionnaire is a validated measure of social support. For each item, respondents must choose one answer that reflects their assessment of social support on a 7-point scale.19 The items divide into 3 main factors of support: Family, Friends, and Significant other.
Change in baseline social support at 3 month and 6 month
LDL levels
Time Frame: Change in baseline LDL level at 6 month
The investigators will obtain baseline LDL levels for each patient prior to the intervention. In addition to monitor impact of adherence to the statin medication the investigators will obtain LDL levels at baseline and 6-month time periods for all patients.
Change in baseline LDL level at 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Investigators

  • Principal Investigator: Ashok Reddy, MD, University of Pennsylvania/Philadelphia VAMC
  • Principal Investigator: Judith Long, MD, University of Pennsylvania Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 3, 2015

Study Completion (Actual)

September 3, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Individual Feedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe