Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 8:18 PM
Study NCT ID:
NCT07084051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improve Medication Adherence Among Stroke Survivors in Rural Kentucky
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], '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': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Medication Adherence Questionnaire', 'timeFrame': 'Baseline and at 3 months', 'description': 'Medication adherence is measured using a 12-item questionnaire that determines how often medications are missed. Scores range from 12 to 48 with lower scores indicating better adherence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke (CVA) or Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': 'To test the feasibility and promise of a combined intervention provided by community health worker (CHW) in collaboration with pharmacy technician and pharmacist to improve hypertension and long-term stroke outcomes by identifying and reducing barriers to medication adherence among ischemic stroke survivors. This collaborative intervention involves a self-management program including an educational session on practical strategies to improve hypertension control (i.e., appropriately taking medications, necessity of treatment, and consequences of not taking medicine, etc.), complemented by individually-tailored sessions to identify and address barriers to medication adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with history of ischemic stroke or transient ischemic attack (TIA) in the past 2 years\n* residing in a rural county in Kentucky\n\nExclusion Criteria:\n\n* significant aphasia\n* cognitive impairment\n* a terminal illness\n* other neurologic deficits that would impede from providing informed consent or meaningfully participate in the one-to-one sessions.\n* a prior aneurysmal subarachnoid hemorrhage and or aneurysm, cerebral venous sinus thrombosis, vasculitis, blood clotting disorder due to genetic causes\n* if the patient does not take any secondary preventative medications'}, 'identificationModule': {'nctId': 'NCT07084051', 'acronym': 'I-MAS', 'briefTitle': 'Improve Medication Adherence Among Stroke Survivors in Rural Kentucky', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Intervention to Improve Medication Adherence Among Stroke Survivors in Rural Kentucky', 'orgStudyIdInfo': {'id': '101375'}, 'secondaryIdInfos': [{'id': '1P50MD019476-01', 'link': 'https://reporter.nih.gov/quickSearch/1P50MD019476-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke Survivors', 'description': 'self-management program with an an educational session and an individually-tailored session on medication adherence.', 'interventionNames': ['Behavioral: I-MAS']}], 'interventions': [{'name': 'I-MAS', 'type': 'BEHAVIORAL', 'otherNames': ['Improve Medication Adherence Among Stroke Survivors'], 'description': 'Participants will receive a one-to one session with the pharmacy technician that involves two parts; the first part include education on ischemic stroke and risk factors such as practical strategies to improve hypertension control (i.e., appropriately taking medications, necessity of treatment, and consequences of not taking medicine, etc., making healthier dietary choices, exercising regularly, smoking cessation, alcohol intake, and managing blood sugar. The second part involves an interview to collect information on socio-demographics, clinical factors, co-morbidities, medications, and medication adherence barriers. During the second part of the session, the pharmacy technician will identify barriers to medication adherence for secondary prevention of stroke medications including antihypertensives, antithrombotic agents, and statins. The pharmacist will collaborate with the pharmacy technician to develop an action plan to address medication adherence barriers', 'armGroupLabels': ['Stroke Survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40356', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Hend Mansoor, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hend Mansoor', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hend Mansoor', 'investigatorAffiliation': 'University of Kentucky'}}}}