Telehealth-Enhanced Assessment and Management

NCT ID: NCT06247254

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2028-07-31

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.

Conditions

Blood Pressure

Keywords

Hypertension; Stroke; Cardiovascular events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intensive Tailored Telehealth Management (ITTM)

ITTM is a novel adaptation of the Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink) model, based on the premise that patients have social and functional barriers to blood pressure management. In the ITTM arm, barriers to care are identified and addressed through Blood Pressure Care Plan messaging and referrals to needed resources. The ITTM intervention includes a tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. INTERVENT services may be reimbursed using Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) insurance billing codes. Blood pressure monitors and wearable physical activity trackers will be provided to participants as part of the study.

Group Type: EXPERIMENTAL

Intensive Tailored Telehealth Management

Intervention Type: BEHAVIORAL

Tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT.

Intensive Clinic Management (ICM)

ICM is based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) model and includes 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. Blood pressure monitors will be provided as part of the study.

Group Type: OTHER

Intensive Clinic Management

Intervention Type: BEHAVIORAL

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.

Interventions

Intensive 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.

Intervention Type: BEHAVIORAL

Intensive Tailored Telehealth Management

Tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT.

Intervention Type: BEHAVIORAL

Other Intervention Names

ICM; ITTM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Bushnell, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Wayne Rosamond, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

2020C3-21070

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00114353

Identifier Type: -

Identifier Source: org_study_id