The "Savvy for Stroke Survivors" Study: Testing a Novel Tool to Help Stroke Survivors Take Their Medication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Self-Reported Medication Adherence
研究概览
简要总结
The goal of this study is to test if Savvy, a multimodal intervention (consisting of psychological exercises, a weekly pill organizer, and a text message reminder system) can improve medication adherence in stroke survivors.
The main questions it aims to answer are:
- Can the Savvy tool improve medication adherence in stroke survivors compared to usual care?
- Does the use of the Savvy tool lead to better blood pressure control after a stroke?
The investigators will compare the use of the Savvy intervention to a control group that receives usual care, including a package of educational materials.
The study consists of the following components:
- Participants will receive the Savvy intervention or usual care. The intervention package consists of short psychological exercises over the phone, a weekly medication organizer to support daily medication intake, and text message reminders to take medication and refill the medication box. Participants in the control group will receive usual care, including educational materials about the importance of blood pressure and medication.
- All participants will receive a free home blood pressure monitor and will be requested to measure their blood pressure at certain time points during the study.
- Participants will be enrolled in the study for 6 months and will have virtual follow-up calls at 3 and 6 months.
详细描述
The investigators will conduct a randomized controlled trial to evaluate the preliminary efficacy of the Savvy intervention, an intervention incorporating psychological strategies and practical tools to improve medication adherence and blood pressure control among stroke survivors.
A total of 150 stroke survivors will be enrolled and followed longitudinally for a duration of 6 months. Stratified randomization will be performed in a 1:1 ratio for the Savvy intervention and control group.
The intervention group will receive the Savvy intervention and a free BP monitor to support their medication intake. The control group will also receive the free BP monitor, as well as access to educational materials about blood pressure management. All participants will complete study assessments at baseline, and at 3 and 6 months of enrollment.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between the ages of 18 years old and 99 years old at the time of consent.
- •Self-reported primary diagnosis of stroke (ischemic or hemorrhagic) within the past 12 months, without structural, traumatic or secondary causes (including aneurysm, arteriovenous malformation, or tumor).
- •Currently prescribed an antihypertensive regimen.
- •Currently less than optimal adherence to medication, defined as a score <25 on the Medication Adherence Report Scale (MARS-5).
- •Cognitively able to manage medications independently, defined as a score of >4 on the Six-Item Screener (SIS) for cognitive impairment.
- •Speaks English sufficiently to complete consent and study procedures.
- •Has access to a phone that can receive text messages and is able to participate in scheduled phone-based follow-up assessments.
- •Uses, or willing to start using, a single pharmacy chain for prescription refills and is willing to provide consent for the study team to contact the pharmacy to retrieve prescription refill data.
- •Willing and able to provide informed consent.
排除标准
- •Prescribed a more than three scheduled daily medication doses.
- •Prescribed a complex medication regimen requiring more than five additional oral medications per dose time.
- •Diagnosed with secondary hypertension or other BP conditions not managed with standard oral antihypertensives.
- •Has upper extremity impairments or other physical limitations that prevent safe use of the medication box or BP monitor.
- •Lives in an environment where the medication organizer cannot be safely or consistently accessed, such as in temporary housing, shelters, or unstable living conditions.
- •Diagnosed with moderate-to-severe cognitive impairment, dementia, or active psychiatric instability that precludes informed consent or reliable participation.
- •Known allergy or contraindication to the materials used in the BP monitor or the medication box.
- •Participation in another intervention trial targeting medication adherence or BP control.
- •Planned relocation or anticipated unavailability for the 12-month study period.
研究组 & 干预措施
Control Group
The control group will receive access to educational materials about the importance of blood pressure control and medication adherence, along with a home blood pressure monitor.
Savvy Group
The intervention group will receive the Savvy intervention to support medication adherence, consisting of psychological exercises, a weekly pill organizer, and a text messaging reminder system. Additionally, the intervention group will receive the same educational materials and home blood pressure monitor as the control group.
干预措施: Savvy Medication Adherence Intervention (Behavioral)
结局指标
主要结局
Self-Reported Medication Adherence
时间窗: 6 months
The primary outcome is self-reported medication adherence using the validated Medication Adherence Report Scale (MARS-5). The MARS-5 scores ranges from 5-25; higher scores indicate better adherence.
次要结局
- Blood Pressure Improvement(3 and 6 months)
- Blood pressure control(3 and 6 months)
- Self-Reported Medication Adherence at 3 months(3 months)
研究者
Sanjula Dhillon Singh, MD PhD MS
Instructor of Neurology, Principal Investigator
Massachusetts General Hospital