Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)

Wake Forest University (WFU)

Status

Completed

Conditions

Hypertension Secondary

Treatments

Behavioral: Intensive tailored telehealth management (ITTM)

Behavioral: Intensive Clinic Management (ICM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05539443

IRB00085596

PLACER-02020C3-21070 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment

74 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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