ClinicalTrials.gg
RecruitingNCT07414732Updated May 20, 2026

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

An interventional study of Savvy Medication Adherence Intervention in Stroke, Intracerebral Haemorrhage and Ischemic Stroke, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Primary conditionIschemic StrokeRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Ischemic Stroke
Why
  1. The study's listed conditions name Ischemic Stroke, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Stroke
  • Intracerebral Haemorrhage
  • Ischemic Stroke
  • TIA (Transient Ischemic Attack)

Keywords

  • Medication Adherence
  • Motivational Interviewing (MI)
  • Blood pressure
  • Stroke
  • Secondary Prevention
03

In context

Ischemic Stroke Reclassified

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 or reliable participation.
  7. Known allergy or 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study 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.

    Behavioral: Savvy Medication Adherence Intervention

Interventions

  • BehavioralSavvy 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.

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Blood Pressure Improvement

    Defined as the proportion of patients who achieved a 10-mmHg reduction in systolic blood pressure

    Time frame: 3 and 6 months

  2. Blood pressure control

    The proportion of participants achieving a blood pressure of \<130/80mmHg

    Time frame: 3 and 6 months

  3. Self-Reported Medication Adherence at 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.

    Time frame: 3 months

07

Study locations

1 of 2 sites recruiting
08

References and documents

Publications

  • 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. PubMed 21896153 ↗
  • 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. PubMed 34024117 ↗
  • 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. PubMed 24490648 ↗
  • 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. PubMed 30006474 ↗
  • 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. PubMed 27371106 ↗
  • 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. PubMed 22269592 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Feb 17, 2026
StartActual
Mar 31, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07414732
Responsible party
Sanjula Dhillon Singh, MD PhD MS (Instructor of Neurology, Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Feb 17, 2026
Start date
Mar 31, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Sanjula Singh, MD PhD
Contact
SSINGH32@mgh.harvard.edu
6177265358
Evy Reinders, MD
Contact
ereinders@mgh.harvard.edu
Sanjula Singh, MD PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion