Using Feedback Reports to Improve Medication Adherence

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480530
• Other study ID #: 01461
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: January 26, 2018
• Start date: January 2014
• Est. completion date: September 3, 2015

Study information

• Verified date: January 2018
• Source: Corporal Michael J. Crescenz VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 3, 2015
• Est. primary completion date: September 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Individual Feedback
Patient gets feedback reports on adherence weekly.
• Feedback Friend
In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

Locations

Country	Name	City	State
United States	Philadelphia VA Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corporal Michael J. Crescenz VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change in baseline patient activation at 3 month and 6 month
Secondary	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.	Change in baseline social support at 3 month and 6 month
Secondary	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.	Change in baseline LDL level at 6 month