Clinical trial NCT06247254: Telehealth-Enhanced Assessment and Management
Official title: Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Keywords: Hypertension
Stroke
Cardiovascular events
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attaining the Target Systolic Blood Pressure of <130 mmHg
timeFrame: Month 6
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke
timeFrame: Baseline to Month 6
measure: Number of major adverse cardiovascular events (MACE)
timeFrame: Month 12
measure: Change in Patient Activation Measured with the Patient Activation Measure (PAM)
timeFrame: Month 6
Other outcomes:
measure: Change in blood pressures following treatment
timeFrame: Month 3 to Month 12
measure: Change in Cognitive function scores as assessed by the Montreal Cognitive Assessment (MoCA) scores
timeFrame: Baseline to Month 6, Baseline to Month 12
measure: Change in (PROMIS) Patient-Reported Outcomes Measurement Information System Scores
timeFrame: Baseline to Month 6, Baseline to Month 12
measure: Change in Modified Rankin Scale (mRS) Scores
timeFrame: Baseline to Month 6, Baseline to Month 12
measure: Change in Medication Adherence
timeFrame: Baseline at 6 months,, Baseline to 12 months
measure: Patient Satisfaction Score
timeFrame: Month 6
measure: Treatment Burden Score
timeFrame: Month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Cheryl Bushnell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Wayne Rosamond, MD
role: PRINCIPAL_INVESTIGATOR
References: