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

NCT07414732 | Recruiting

• 1 other identifier: 2025P002230
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self-Reported Medication Adherence

  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 Outcomes (3)

• Blood Pressure Improvement

  3 and 6 months

• Blood pressure control

  3 and 6 months

• Self-Reported Medication Adherence at 3 months

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Savvy Group

EXPERIMENTAL

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

Interventions

Savvy Medication Adherence Intervention BEHAVIORAL

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.

Savvy Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (6)

• Arima H, Chalmers J. PROGRESS: Prevention of Recurrent Stroke. J Clin Hypertens (Greenwich). 2011 Sep;13(9):693-702. doi: 10.1111/j.1751-7176.2011.00530.x. Epub 2011 Sep 2.

  PMID: 21896153 BACKGROUND

• Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.

  PMID: 34024117 BACKGROUND

• Harris PR, Brearley I, Sheeran P, Barker M, Klein WM, Creswell JD, Levine JM, Bond R. Combining self-affirmation with implementation intentions to promote fruit and vegetable consumption. Health Psychol. 2014 Jul;33(7):729-36. doi: 10.1037/hea0000065. Epub 2014 Feb 3.

  PMID: 24490648 BACKGROUND

• Nolan RP, Feldman R, Dawes M, Kaczorowski J, Lynn H, Barr SI, MacPhail C, Thomas S, Goodman J, Eysenbach G, Liu S, Tanaka R, Surikova J. Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004420. doi: 10.1161/CIRCOUTCOMES.117.004420.

  PMID: 30006474 BACKGROUND

• Wan LH, Zhang XP, Mo MM, Xiong XN, Ou CL, You LM, Chen SX, Zhang M. Effectiveness of Goal-Setting Telephone Follow-Up on Health Behaviors of Patients with Ischemic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2016 Sep;25(9):2259-70. doi: 10.1016/j.jstrokecerebrovasdis.2016.05.010. Epub 2016 Jun 28.

  PMID: 27371106 BACKGROUND

• Ogedegbe GO, Boutin-Foster C, Wells MT, Allegrante JP, Isen AM, Jobe JB, Charlson ME. A randomized controlled trial of positive-affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med. 2012 Feb 27;172(4):322-6. doi: 10.1001/archinternmed.2011.1307. Epub 2012 Jan 23.

  PMID: 22269592 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke; Ischemic Attack, Transient; Medication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sanjula Singh, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjula Singh, MD PhD

CONTACT

6177265358; SSINGH32@mgh.harvard.edu

Evy Reinders, MD

CONTACT

ereinders@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Neurology, Principal Investigator

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)