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Using Feedback Reports to Improve Medication Adherence

Primary Purpose

Coronary Artery Disease, Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual Feedback
Feedback Friend
Sponsored by
Corporal Michael J. Crescenz VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Medication Adherence, Reciprocal Peer, Telemonitoring

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Philadelphia VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Individual Feedback

Feedback Friend

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Adherence
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)].

Secondary Outcome Measures

Patient Activation
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.
Social Support
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.
LDL levels
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.

Full Information

First Posted
May 1, 2014
Last Updated
January 26, 2018
Sponsor
Corporal Michael J. Crescenz VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02480530
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 3, 2015 (Actual)
Study Completion Date
September 3, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Control Group Individual Alarm device and feedback report 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Adherence
Keywords
Medication Adherence, Reciprocal Peer, Telemonitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be given educational material on the importance of adherence to statin medications. The GlowCaps device will be set to only record adherence.
Arm Title
Individual Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Feedback Friend
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Individual Feedback
Intervention Description
Patient gets feedback reports on adherence weekly.
Intervention Type
Behavioral
Intervention Name(s)
Feedback Friend
Intervention Description
In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.
Primary Outcome Measure Information:
Title
Adherence
Description
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)].
Time Frame
Change in baseline adherence at 3 month and 6 month
Secondary Outcome Measure Information:
Title
Patient Activation
Description
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.
Time Frame
Change in baseline patient activation at 3 month and 6 month
Title
Social Support
Description
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.
Time Frame
Change in baseline social support at 3 month and 6 month
Title
LDL levels
Description
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.
Time Frame
Change in baseline LDL level at 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Reddy, MD
Organizational Affiliation
University of Pennsylvania/Philadelphia VAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith Long, MD
Organizational Affiliation
University of Pennsylvania Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27612487
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.
Results Reference
derived

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Using Feedback Reports to Improve Medication Adherence

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