Savvy medication-support program for people after stroke

The "Savvy for Stroke Survivors" Study: Testing a Novel Tool to Help Stroke Survivors Take Their Medication

This project will test whether Savvy — short phone-based psychological exercises, a weekly pill organizer, and text reminders — helps stroke survivors take their blood-pressure medicines and improve blood pressure compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT07414732 on ClinicalTrials.gov

What this trial studies

This is a randomized controlled trial comparing the Savvy multimodal intervention to usual care with educational materials among 150 stroke survivors followed for 6 months. Participants are randomized 1:1 with stratification and complete assessments at baseline, 3 months, and 6 months. The Savvy package combines brief phone-delivered psychological exercises, a weekly medication organizer, and automated text reminders, and both groups receive a free home blood-pressure monitor. The main outcomes are medication adherence and blood pressure control over the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults (18–99) who had a stroke within the past 12 months, are prescribed antihypertensive medication, have suboptimal adherence (MARS-5 < 25), are cognitively able to manage medications (SIS > 4), speak English, and have a phone that can receive texts and use a single pharmacy chain.

Not a fit: Patients who already take medications reliably, have significant cognitive impairment, cannot receive text messages or use a single pharmacy, or who do not speak English are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Savvy could improve adherence to antihypertensive medication and lower blood pressure, reducing the risk of recurrent stroke.

How similar studies have performed: Components like text reminders, pill organizers, and brief motivational approaches have shown modest success in improving adherence in other chronic conditions, but combined multimodal interventions specifically in recent stroke survivors remain relatively untested.

Eligibility criteria

Inclusion criteria:

1. Participants must be between the ages of 18 years old and 99 years old at the time of consent.
2. 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).
3. Currently prescribed an antihypertensive regimen.
4. Currently less than optimal adherence to medication, defined as a score \<25 on the Medication Adherence Report Scale (MARS-5).
5. Cognitively able to manage medications independently, defined as a score of \>4 on the Six-Item Screener (SIS) for cognitive impairment.
6. Speaks English sufficiently to complete consent and study procedures.
7. Has access to a phone that can receive text messages and is able to participate in scheduled phone-based follow-up assessments.
8. 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.
9. Willing and able to provide informed consent.

Exclusion criteria:

1. Prescribed a more than three scheduled daily medication doses.
2. Prescribed a complex medication regimen requiring more than five additional oral medications per dose time.
3. Diagnosed with secondary hypertension or other BP conditions not managed with standard oral antihypertensives.
4. Has upper extremity impairments or other physical limitations that prevent safe use of the medication box or BP monitor.
5. Lives in an environment where the medication organizer cannot be safely or consistently accessed, such as in temporary housing, shelters, or unstable living conditions.
6. Diagnosed with moderate-to-severe cognitive impairment, dementia, or active psychiatric instability that precludes informed consent or reliable participation.
7. Known allergy or contraindication to the materials used in the BP monitor or the medication box.
8. Participation in another intervention trial targeting medication adherence or BP control.
9. Planned relocation or anticipated unavailability for the 12-month study period.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Sanjula Singh, MD PhD — Massachusetts General Hospital
• Study coordinator: Sanjula Singh, MD PhD

Conditions: Stroke, Intracerebral Haemorrhage, Ischemic Stroke, TIA, Medication Adherence, Motivational Interviewing, Blood pressure, Secondary Prevention