Telehealth-Enhanced Assessment and Management

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)

TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.

Hypertension affects nearly half of the US population (46% of adults) and is the strongest risk factor for recurrent stroke. Prevalence in patients with ischemic or hemorrhagic stroke in the US varies by region (highest in the South) ranging from 70% to 82%, and is associated with greater risk of recurrent stroke, major cardiovascular events, and death. A vital question for stroke patients and caregivers is how to prevent a recurrent stroke and further adverse events. Multiple clinical trials have shown that lowering BP reduces the risk for cardiovascular disease and stroke. Few trials, however, included stroke patients with a focus on secondary prevention nor were representative of vulnerable populations. The former US Surgeon General recently published a Call to Action focused on BP with three goals: 1) make hypertension control a national priority; 2) ensure that communities support hypertension control; and 3) optimize patient care for hypertension control.

Inclusion Criteria:

• Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging [MRI]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting > 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI
• Age ≥18 years
• Discharged directly home from acute care or inpatient rehabilitation
• At least one of the following: documented history of hypertension; self-reported history of hypertension; use of
• hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)
• Systolic Blood Pressure ≥ 130 mmHg
• Able to read and understand English or Spanish,
• Have access to a functioning smartphone or tablet with cellular connectivity
• Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet of a qualifying caregiver
• Stated agreement to participate in either intervention to which they are assigned and attend all required study visits,
• Consent to receiving Short Message Service (SMS) required as part of the study interventions
• Consent to enrollment in Chronic Care Management required as part of the study interventions,
• Provision of a signed and dated informed consent form

Exclusion Criteria:

• Subdural hematoma or subarachnoid hemorrhage
• Current participation in another stroke clinical trial precluding dual enrollment
• Presence of terminal illness, such as cancer, that limits life expectancy to <1 year
• Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis
• Pregnancy, lactation or planning to become pregnant
• Late-stage Alzheimer's disease or related dementia
• Transitioned to a facility such as skilled nursing or long-term care prior to enrollment
• Mid upper arm circumference > 45 cm/17.7 inches or < 22 cm / 8.66 inches
• Missing values for Systolic Blood Pressure or Patient Activation Measure (PAM) score at baseline
• Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial