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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Stroke, Acute Ischemic
• Intervention / Treatment: Other: Social Network Group Counseling; Other: Individual Counseling

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. First acute ischemic stroke defined clinically with support from imaging if necessary
2. 21 years of age or older
3. Within 14 days after stroke
4. History of hypertension or has been newly prescribed blood pressure medications during index admission

Exclusion Criteria:

1. Prior ischemic or hemorrhagic stroke
2. NIHSS > 21
3. Significant aphasia (Score>1 on the language section of the NIHSS)
4. Medical conditions for which death is likely within 6 months
5. Does not have capacity to consent for the project or participate in survey interview
6. Diagnosis of dementia
7. Patient has no phone or incapable of using text messages
8. Patient has opted out of participating in research noted within MGB Epic EHR system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Network Counseling; 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; 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.
Active Comparator: Individual Counseling; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 27, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Social Networks
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2022P000444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No