Tests treatment safety and results for Stroke
Official title Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
ClinicalTrials.gov ID: NCT07414732
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Diagnosed with moderate-to-severe cognitive impairment, dementia, or active psychiatric instability that precludes informed consent or reliable...
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.