Savvy medication-support program for people after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Active not recruiting

Study contacts

• Principal investigator: Sanjula Singh, MD PhD — Massachusetts General Hospital
• Study coordinator: Sanjula Singh, MD PhD
• Email: SSINGH32@mgh.harvard.edu
• Phone: 6177265358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.