Recruiting

Savvy

Sponsor:

Massachusetts General Hospital

Code:

NCT07414732

Conditions

Stroke

Intracerebral Haemorrhage

Ischemic Stroke

TIA (Transient Ischemic Attack)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Savvy Medication Adherence Intervention

Study Details

Brief 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.

Conditions

Stroke

Intracerebral Haemorrhage

Ischemic Stroke

TIA (Transient Ischemic Attack)

Study ID

NCT07414732

Start date

Mar 31, 2026

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

Interventions

Savvy Medication Adherence Intervention

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.

Primary outcome measure

  • Self-Reported Medication Adherence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sanjula Singh, MD, PhD, MSc

617-726-5358mgposavvy@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 20, 2026

Last verified

Mar, 2026

Keywords

  • Medication Adherence
  • Motivational Interviewing (MI)
  • Blood pressure
  • Stroke
  • Secondary Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-20.