Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07414732
Eligibility Criteria:
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 informed consent.
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 informed consent or reliable participation.
7. Known allergy or contraindication 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT07414732
Study Brief:
Protocol Section:
NCT07414732