Telehealth-Enhanced Assessment and Management

Not Applicable

Recruiting

• Conditions: Blood Pressure
• Interventions: Behavioral: Intensive Clinic Management; Behavioral: Intensive Tailored Telehealth Management

• Registration Number: NCT06247254
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-11
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Clinic Management (ICM)	Intensive Clinic Management	The ICM arm includes BP management at in-person follow-up visits occurring every 2 months when BPs are at target and if not in target, monthly visits. Medications will be adjusted to lower BP to the target using evidence-based guidelines and in the context of whether the participant can effectively manage their medications and BP. ICM participants will receive a COMPASS Care plan, which will evaluate social and functional factors for managing stroke recovery.
Intensive Tailored Telehealth Management (ITTM)	Intensive Tailored Telehealth Management	The ITTM intervention involves a comprehensive, multi-dimensional approach to using real-time BP data to manage BP after stroke. ITTM includes an in-person visit during which participants will complete a series of questionnaires within the COMPASS-CP® web application and will receive a COMPASS-BP Action Plan home safety checklist, Blood Pressure (BP) Matters documents, and referrals to local resources, as needed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States