StrokeNCT07414732
Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
A study testing Savvy Medication Adherence Intervention in people with Stroke and Intracerebral Haemorrhage, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Intracerebral Haemorrhage, Ischemic Stroke
- What is being tested?
- Savvy Medication Adherence Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Evy Reinders, MD contact
United States2 sites, 1 recruiting
- Active, not recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sanjula Singh, MD, PhD, MSc, 617-726-5358, mgposavvy@mgb.org
About this study
Official title: 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:
Read more
- 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.
- Being tested
- Savvy Medication Adherence Intervention
- Keywords
- Medication Adherence, Motivational Interviewing (MI), Blood pressure, Stroke, Secondary Prevention
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Ischemic Stroke, Ischemic Attack, Transient, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savvy Medication Adherence InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Savvy Medication Adherence Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Blood Pressure Improvement
Defined as the proportion of patients who achieved a 10-mmHg reduction in systolic blood pressure
Measured: 3 and 6 months
Blood pressure control
The proportion of participants achieving a blood pressure of <130/80mmHg
Measured: 3 and 6 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjula Dhillon Singh, MD PhD MS, Massachusetts General Hospital
- Investigators
- Sanjula Singh, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414732
- Sponsor's protocol ID
- 2025P002230
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21896153Kleindorfer 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 34024117Harris 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 24490648Nolan 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 30006474Wan 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 27371106Ogedegbe 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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Savvy for Stroke Survivors" Study: Testing a Novel Tool to Help Stroke Survivors Take Their Medication
- ClinicalTrials.gov ID
- NCT07414732
- Acronym / sponsor ID
- 2025P002230
- Keywords
- Medication Adherence, Motivational Interviewing (MI), Blood pressure, Stroke, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Savvy Medication Adherence InterventionThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Savvy Medication Adherence InterventionThe 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. | Behavioural | Savvy Group |
Primary outcome
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.
3 secondary outcomes
Blood Pressure Improvement
Time frame: 3 and 6 months
Blood pressure control
Time frame: 3 and 6 months
Self-Reported Medication Adherence at 3 months
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 21896153Arima 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.
- Background: PubMed 34024117Kleindorfer 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.
- Background: PubMed 24490648Harris 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.
- Background: PubMed 30006474Nolan 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.
- Background: PubMed 27371106Wan 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.
- Background: PubMed 22269592Ogedegbe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evy Reinders, MD contact
Sanjula Singh, MD PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savvy Medication Adherence Intervention in people with Stroke and Intracerebral Haemorrhage, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjula Singh, MD PhD (6177265358, SSINGH32@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Medication Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414732, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.