Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors

May 19, 2026 updated by: Sanjula Dhillon Singh, MD PhD MS, Massachusetts General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a randomized controlled trial to evaluate the preliminary efficacy of the Savvy intervention, an intervention incorporating psychological strategies and practical tools to improve medication adherence and blood pressure control among stroke survivors.

A total of 150 stroke survivors will be enrolled and followed longitudinally for a duration of 6 months. Stratified randomization will be performed in a 1:1 ratio for the Savvy intervention and control group.

The intervention group will receive the Savvy intervention and a free BP monitor to support their medication intake. The control group will also receive the free BP monitor, as well as access to educational materials about blood pressure management. All participants will complete study assessments at baseline, and at 3 and 6 months of enrollment.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Active, not recruiting
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Medication Adherence
Time Frame: 6 months
The primary outcome is self-reported medication adherence using the validated Medication Adherence Report Scale (MARS-5). The MARS-5 scores ranges from 5-25; higher scores indicate better adherence.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Improvement
Time Frame: 3 and 6 months
Defined as the proportion of patients who achieved a 10-mmHg reduction in systolic blood pressure
3 and 6 months
Blood pressure control
Time Frame: 3 and 6 months
The proportion of participants achieving a blood pressure of <130/80mmHg
3 and 6 months
Self-Reported Medication Adherence at 3 months
Time Frame: 3 months
Self-reported medication adherence measured using the Medication Adherence Report Scale (MARS-5) at 3 months. Scores range from 5-25; higher scores indicate better adherence.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Sanjula Singh, MD PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P002230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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