Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survi… (NCT07414732) | Clinical Trial Compass
RecruitingNot Applicable
Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
United States150 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.