Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:53 AM
Study NCT ID:
NCT07414732
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Reported Medication Adherence', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Improvement', 'timeFrame': '3 and 6 months', 'description': 'Defined as the proportion of patients who achieved a 10-mmHg reduction in systolic blood pressure'}, {'measure': 'Blood pressure control', 'timeFrame': '3 and 6 months', 'description': 'The proportion of participants achieving a blood pressure of \\<130/80mmHg'}, {'measure': 'Self-Reported Medication Adherence at 3 months', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication Adherence', 'Motivational Interviewing (MI)', 'Blood pressure', 'Stroke', 'Secondary Prevention'], 'conditions': ['Stroke', 'Intracerebral Haemorrhage', 'Ischemic Stroke', 'TIA (Transient Ischemic Attack)']}, 'referencesModule': {'references': [{'pmid': '21896153', 'type': 'BACKGROUND', 'citation': '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': '34024117', 'type': 'BACKGROUND', 'citation': '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': '24490648', 'type': 'BACKGROUND', 'citation': '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': '30006474', 'type': 'BACKGROUND', 'citation': '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': '27371106', 'type': 'BACKGROUND', 'citation': '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': '22269592', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Can the Savvy tool improve medication adherence in stroke survivors compared to usual care?\n* Does the use of the Savvy tool lead to better blood pressure control after a stroke?\n\nThe investigators will compare the use of the Savvy intervention to a control group that receives usual care, including a package of educational materials.\n\nThe study consists of the following components:\n\n* 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.\n* 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.\n* Participants will be enrolled in the study for 6 months and will have virtual follow-up calls at 3 and 6 months.', 'detailedDescription': '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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Participants must be between the ages of 18 years old and 99 years old at the time of consent.\n2. 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).\n3. Currently prescribed an antihypertensive regimen.\n4. Currently less than optimal adherence to medication, defined as a score \\<25 on the Medication Adherence Report Scale (MARS-5).\n5. Cognitively able to manage medications independently, defined as a score of \\>4 on the Six-Item Screener (SIS) for cognitive impairment.\n6. Speaks English sufficiently to complete consent and study procedures.\n7. Has access to a phone that can receive text messages and is able to participate in scheduled phone-based follow-up assessments.\n8. 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.\n9. Willing and able to provide informed consent.\n\nExclusion criteria:\n\n1. Prescribed a more than three scheduled daily medication doses.\n2. Prescribed a complex medication regimen requiring more than five additional oral medications per dose time.\n3. Diagnosed with secondary hypertension or other BP conditions not managed with standard oral antihypertensives.\n4. Has upper extremity impairments or other physical limitations that prevent safe use of the medication box or BP monitor.\n5. Lives in an environment where the medication organizer cannot be safely or consistently accessed, such as in temporary housing, shelters, or unstable living conditions.\n6. Diagnosed with moderate-to-severe cognitive impairment, dementia, or active psychiatric instability that precludes informed consent or reliable participation.\n7. Known allergy or contraindication to the materials used in the BP monitor or the medication box.\n8. Participation in another intervention trial targeting medication adherence or BP control.\n9. Planned relocation or anticipated unavailability for the 12-month study period.'}, 'identificationModule': {'nctId': 'NCT07414732', 'briefTitle': 'Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The "Savvy for Stroke Survivors" Study: Testing a Novel Tool to Help Stroke Survivors Take Their Medication', 'orgStudyIdInfo': {'id': '2025P002230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Savvy Group', 'description': '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.', 'interventionNames': ['Behavioral: Savvy Medication Adherence Intervention']}], 'interventions': [{'name': 'Savvy Medication Adherence Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Savvy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanjula Singh, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'mgposavvy@mgb.org', 'phone': '617-726-5358'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Sanjula Singh, MD PhD', 'role': 'CONTACT', 'email': 'SSINGH32@mgh.harvard.edu', 'phone': '6177265358'}, {'name': 'Evy Reinders, MD', 'role': 'CONTACT', 'email': 'ereinders@mgh.harvard.edu'}], 'overallOfficials': [{'name': 'Sanjula Singh, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor of Neurology, Principal Investigator', 'investigatorFullName': 'Sanjula Dhillon Singh, MD PhD MS', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}