Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

NCT ID: NCT05539443

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-09-30

Brief Summary

TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke

Detailed Description

The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).

Conditions

Hypertension Secondary

Study Design

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

Study Groups

Intensive Clinic Management (ICM)

Group Type: EXPERIMENTAL

Intensive Clinic Management (ICM)

Intervention Type: BEHAVIORAL

An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial

Intensive tailored telehealth management (ITTM)

Group Type: EXPERIMENTAL

Intensive tailored telehealth management (ITTM)

Intervention Type: BEHAVIORAL

A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial

Interventions

Intensive Clinic Management (ICM)

An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial

Intervention Type: BEHAVIORAL

Intensive tailored telehealth management (ITTM)

A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial

Intervention Type: BEHAVIORAL

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
• SBP>130 at the post-acute clinic visit (within 21 days of discharge) & at Study Visit 1 (within 31 days of discharge)
• Able to read and understand English or Spanish
• Have access to a functioning smartphone or tablet with broadband access (required for the intervention)
• Willing to install and use a study-compatible physical activity monitoring application on their smartphone or smartphone 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
• 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
• 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
• Maximum Eligible Age: 75 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 Health Sciences

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

PLACER-02020C3-21070

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00085596

Identifier Type: -

Identifier Source: org_study_id