TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)

Study Overview
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Brief Summary
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This study aims to compare the efficacy of a social network intervention versus individual hypertension counseling to improve blood pressure control after stroke. The investigators hope to understand whether the involvement of family, friends and other members of individual's social network can help achieve better blood pressure after experiencing a stroke. Participants will be stratified to two groups according to network size (<5 vs 5 or more) and randomized to receive individual hypertension counseling (control) or the social network intervention. The primary outcome of the study will be the absolute reduction in systolic blood pressure at 3 months follow-up. The secondary outcomes will be attainment of a post-stroke hypertension treatment goal and patient-reported physical function.

Official Title
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TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure): A Randomized Control Trial

Conditions
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Stroke, Acute Ischemic, Hypertension

Intervention / Treatment
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* Other: Social Network Group Counseling
* Other: Individual Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First acute ischemic stroke defined clinically with support from imaging if necessary 21 years of age or older Within 14 days after stroke History of hypertension or has been newly prescribed blood pressure medications during index admission Exclusion Criteria: Prior ischemic or hemorrhagic stroke NIHSS > 21 Significant aphasia (Score>1 on the language section of the NIHSS) Medical conditions for which death is likely within 6 months Does not have capacity to consent for the project or participate in survey interview Diagnosis of dementia Patient has no phone or incapable of using text messages Patient has opted out of participating in research noted within MGB Epic EHR system

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Network Counseling<br>The index patient and influential social network members will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for teamwork counseling and blood pressure education. | Other: Social Network Group Counseling<br>* Researchers will identify the influential network members based on their network position, driving distance from the patient, speaking frequency, and whether they have high blood pressure. The index patient and social network members will meet with the study nurse on weeks 2, 6, and 12 after initial enrollment. The study nurse will begin the social network counseling session in which she will provide counseling on teamwork and blood pressure control. The teamwork specific topics will include how networks can work together as a team, communication tips for engaging with one another, spreading positive messages, and establishing the roles and responsibilities of each network team member. The blood pressure control specific topics will include the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. Patient and social network members will receive text messages every week in the weeks between sessions.<br>|
| Active Comparator: Individual Counseling<br>The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education. | Other: Individual Counseling<br>* The index patient will meet individually with the study nurse on weeks 2, 6, and 12 after initial enrollment. The nurse will provide counseling on the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. The patient will receive text messages every week in the weeks between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Change in systolic blood pressure will be evaluated as an absolute reduction in systolic blood pressure at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of post-stroke hypertension treatment goal | This will be evaluated as achieving a blood pressure of <130/80 | 3 months | 
| Patient reported physical function | This will be evaluated using the validated PROMIS questionnaire | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Networks