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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
74
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
A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Proportion of participants with 3-month SBP control
Time frame: 3 months
Mean change in systolic blood pressure (SBP) at 3 months
Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2).
Time frame: Baseline, 3 month
Mean change in Partners in Health Scale (PIH) score at 3 months
Each of the 11 items on the PIH have eight response options ranging from (0) very good to (8) very poor. To calculate the total PIH score, the raw score is summed and transformed to a range \[0,100\], with lower PIH scores indicating higher patient activation.
Time frame: Baseline, 3 month
Proportion of participants eligible among those screened
Time frame: 3 Month
Proportion of participants providing written informed consent among those eligible
Time frame: Baseline
Proportion of participants attending both visits among those who are randomized in the study
Time frame: 3 months
Systolic Blood Pressure Mean Value
Time frame: 3 months
Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)
The overall experience (Overall Rating) is rated on a 10-point scale from 0 (Worst) to 10 (Best). The top score is for overall score includes all participants that responded 9 or 10.
Time frame: 3 months
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Proportion of participants billed
Proportion of participants for which coaching or remote physiologic monitoring services were billed (at any point during the study) using Current Procedural Terminology (CPT) billing codes.
Time frame: 3 months