Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Study Overview
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Brief Summary
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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
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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).

Official Title
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Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Conditions
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Hypertension Secondary

Intervention / Treatment
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* Behavioral: Intensive Clinic Management (ICM)
* Behavioral: Intensive tailored telehealth management (ITTM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Clinic Management (ICM)<br> | Behavioral: Intensive Clinic Management (ICM)<br>* 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<br>|
| Experimental: Intensive tailored telehealth management (ITTM)<br> | Behavioral: Intensive tailored telehealth management (ITTM)<br>* A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with 3-month SBP control |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline, 3 month | 
| Proportion of participants eligible among those screened |  | 3 Month | 
| Proportion of participants providing written informed consent among those eligible |  | Baseline | 
| Proportion of participants attending both visits among those who are randomized in the study |  | 3 months | 
| Systolic Blood Pressure Mean Value |  | 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. | 3 months | 
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypertension after stroke