NCT07414732 · Massachusetts General Hospital
Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
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.
- Planned relocation or anticipated unavailability for the 12-month study period.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations