Assessing the Impact of Low-Touch Devices on Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53,480
- 试验地点
- 1
- 主要终点
- Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
研究概览
简要总结
The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.
详细描述
Prior to randomization, all patients meeting the inclusion criteria stratified into two strata and two blocks within each strata. The first stratum will consist of all patients on 1 to 3 medications for cardiovascular or other non-depression chronic conditions who are suboptimally adherent to these therapies. The second stratum will include all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, each stratum will be further stratified into two separate blocks based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with usual care. Patients for whom all medications are dosed once daily will be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period prior to study eligibility evaluation
- •Cardiovascular disease (defined as hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, or diabetes); OR
- •Another non-depression chronic condition (defined as breast cancer, benign prostatic hypertrophy, schizophrenia, bipolar disorder, anxiety, arrythmia; Parkinson's disease, seizure, and epilepsy); OR
- •Depression
- •Be suboptimally adherent to their qualifying medications, defined as a Medication Possession Ratio between 30% and 80% during the 12 months preceding identification of study eligibility
- •Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period.
排除标准
- •Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal).
研究组 & 干预措施
All meds but depression, 1x daily use, RxTimerCap
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap.
干预措施: RxTimerCap (Behavioral)
All meds but depression, 1x daily use, Take-N-Slide
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide.
干预措施: Take-N-Slide (Behavioral)
All meds but depression, 1x daily use, pillbox
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox.
干预措施: Pillbox (Behavioral)
All meds but depression, 1x daily use, control
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care.
All meds but depression, ≥1 med >1 daily use, RxTimerCap
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap.
干预措施: RxTimerCap (Behavioral)
All meds but depression, ≥1 med >1 daily use, pillbox
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox.
干预措施: Pillbox (Behavioral)
All meds but depression, ≥1 med >1 daily use, control
Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care.
Only depression meds, 1x daily use, RxTimerCap
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap.
干预措施: RxTimerCap (Behavioral)
Only depression meds, 1x daily use, Take-N-Slide
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide.
干预措施: Take-N-Slide (Behavioral)
Only depression meds, 1x daily use, pillbox
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox.
干预措施: Pillbox (Behavioral)
Only depression meds, 1x daily use, control
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care.
Only depression meds, ≥1 med >1 daily use, RxTimerCap
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap.
干预措施: RxTimerCap (Behavioral)
Only depression meds, ≥1 med >1 daily use, pillbox
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox.
干预措施: Pillbox (Behavioral)
Only depression meds, ≥1 med >1 daily use, control
Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care.
结局指标
主要结局
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
时间窗: 12 months
Optimal adherence to all cardiovascular or non-depression chronic disease medications, defined as a Medication Possession Ratio (MPR) equal to or greater than 80% and assessed using administrative pharmacy claims
次要结局
- Optimal adherence to antidepressants(12 months)
- Optimal adherence to the targeted therapies in each randomization block independently(12 months)
- Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization(12 months)
研究者
Niteesh K. Choudhry, MD, PhD
Associate Professor, Harvard Medical School
Brigham and Women's Hospital