NCT07084051

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

July 16, 2025

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Medication Adherence Questionnaire

    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

    Baseline and at 3 months

Study Arms (1)

Stroke Survivors

EXPERIMENTAL

self-management program with an an educational session and an individually-tailored session on medication adherence.

Behavioral: I-MAS

Interventions

I-MASBEHAVIORAL

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

Also known as: Improve Medication Adherence Among Stroke Survivors
Stroke Survivors

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with history of ischemic stroke or transient ischemic attack (TIA) in the past 2 years
  • residing in a rural county in Kentucky

You may not qualify if:

  • significant aphasia
  • cognitive impairment
  • a terminal illness
  • other neurologic deficits that would impede from providing informed consent or meaningfully participate in the one-to-one sessions.
  • a prior aneurysmal subarachnoid hemorrhage and or aneurysm, cerebral venous sinus thrombosis, vasculitis, blood clotting disorder due to genetic causes
  • if the patient does not take any secondary preventative medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40356, United States

Location

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Hend Mansoor, PharmD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

July 24, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations