Using Feedback Reports to Improve Medication Adherence
Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2015
CompletedJanuary 30, 2018
January 1, 2018
1.7 years
May 1, 2014
January 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence
Adherence will be measured using the following formula: \[Number of times the pill bottle was opened/(Number of times a day each medication is prescribed to be taken multiplied by the total number of days in study)\].
Change in baseline adherence at 3 month and 6 month
Secondary Outcomes (3)
Patient Activation
Change in baseline patient activation at 3 month and 6 month
Social Support
Change in baseline social support at 3 month and 6 month
LDL levels
Change in baseline LDL level at 6 month
Study Arms (3)
Control
NO INTERVENTIONPatients will be given educational material on the importance of adherence to statin medications. The GlowCaps device will be set to only record adherence.
Individual Feedback
EXPERIMENTALIn 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.
Feedback Friend
EXPERIMENTALThe 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
Interventions
Patient gets feedback reports on adherence weekly.
In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 27612487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashok Reddy, MD
University of Pennsylvania/Philadelphia VAMC
- PRINCIPAL INVESTIGATOR
Judith Long, MD
University of Pennsylvania Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
June 24, 2015
Study Start
January 1, 2014
Primary Completion
September 3, 2015
Study Completion
September 3, 2015
Last Updated
January 30, 2018
Record last verified: 2018-01