Blood Pressure
Conditions
Keywords
Hypertension, Stroke, Cardiovascular events
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.
Interventions
BEHAVIORALIntensive Clinic Management
Blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., \< 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs.
BEHAVIORALIntensive Tailored Telehealth Management
Tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attaining the Target Systolic Blood Pressure of <130 mmHg | Month 6 | Systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols at 6 months (Study Visit 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke | Baseline to Month 6 | Defined as the systolic blood pressure at baseline (Visit 1) subtracted from the systolic blood pressure at 6 months (Visit 3). At both time points, systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols |
| Number of major adverse cardiovascular events (MACE) | Month 12 | Prevalence of major adverse cardiovascular events (MACE) - death or hospitalization from myocardial infarction, coronary heart disease, or stroke - within 1 year following randomization. |
| Change in Patient Activation Measured with the Patient Activation Measure (PAM) | Month 6 | Defined as the PAM Score at baseline (Visit 1) subtracted from the PAM Score at 6 months (Visit 3). The PAM is a validated 13-item patient-reported outcome measure (PROM) that measures skills and confidence to self-manage chronic disease. Response options for the 13 items are disagree strongly, disagree, agree, agree strongly with an interval-level scale from 0 to 100. To obtain the total PAM score, a propriety scoring algorithm will be used, with higher PAM scores indicating higher patient activation. Change in PAM will be analyzed as a continuous variable. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCheryl Bushnell, MD
Wake Forest University Health Sciences
PRINCIPAL_INVESTIGATORWayne Rosamond, MD
Wake Forest University Health Sciences
Outcome results
None listed