Hypertension Secondary
Conditions
Keywords
Hypertension, Hypertension after stroke
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).
Interventions
BEHAVIORALIntensive 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
BEHAVIORALIntensive 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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with 3-month SBP control | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Partners in Health Scale (PIH) score at 3 months | Baseline, 3 month | 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. |
| Proportion of participants eligible among those screened | 3 Month | — |
| Mean change in systolic blood pressure (SBP) at 3 months | Baseline, 3 month | Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2). |
| Systolic Blood Pressure Mean Value | 3 months | — |
| Proportion of participants attending both visits among those who are randomized in the study | 3 months | — |
| Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS) | 3 months | 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. |
| Proportion of participants billed | 3 months | 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. |
| Proportion of participants providing written informed consent among those eligible | Baseline | — |
Countries
United States
Outcome results
None listed