Telehealth-Enhanced Assessment and Management

NCT06247254 | Active Not Recruiting DMC

• 2 other identifiers: IRB001143532020C3-21070
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Hypertension; Stroke; Cardiovascular events

Outcome Measures

Primary Outcomes (1)

• Attaining the Target Systolic Blood Pressure of <130 mmHg

  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).

  Month 6

Secondary Outcomes (3)

• Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke

  Baseline to Month 6

• Number of major adverse cardiovascular events (MACE)

  Month 12

• Change in Patient Activation Measured with the Patient Activation Measure (PAM)

  Month 6

Other Outcomes (7)

• Change in blood pressures following treatment

  Month 3 to Month 12

• Change in Cognitive function scores as assessed by the Montreal Cognitive Assessment (MoCA) scores

  Baseline to Month 6, Baseline to Month 12

• Change in (PROMIS) Patient-Reported Outcomes Measurement Information System Scores

  Baseline to Month 6, Baseline to Month 12

Study Arms (2)

Intensive Tailored Telehealth Management (ITTM)

EXPERIMENTAL

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.

Behavioral: Intensive Tailored Telehealth Management

Intensive Clinic Management (ICM)

OTHER

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.

Behavioral: Intensive Clinic Management

Interventions

Intensive Clinic Management 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.

Also known as: ICM

Intensive Clinic Management (ICM)

Intensive Tailored Telehealth Management BEHAVIORAL

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

Also known as: ITTM

Intensive Tailored Telehealth Management (ITTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension; Stroke

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cheryl Bushnell, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Wayne Rosamond, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 7, 2024
• Study Start: November 15, 2024
• Primary Completion: February 25, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication - no end date
• Access Criteria: Anyone who wishes to access the data

Locations

US (1)