Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Individual Feedback (Behavioral)
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
干预措施: Individual Feedback (Behavioral)
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
干预措施: Feedback Friend (Behavioral)
结局指标
主要结局
Adherence
时间窗: Change in baseline adherence at 3 month and 6 month
Adherence will be measured using the following formula: \[Number of times the pill bottle was opened/(Number of times a day each medication is prescribed to be taken multiplied by the total number of days in study)\].
次要结局
- Social Support(Change in baseline social support at 3 month and 6 month)
- LDL levels(Change in baseline LDL level at 6 month)
- Patient Activation(Change in baseline patient activation at 3 month and 6 month)