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

NCT ID: NCT05258890

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-01-27

Brief Summary

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.

Conditions

Stroke, Acute Ischemic; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Social Network Group Counseling

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Individual Counseling

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amar Dhand, MD DPhil

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amar Dhand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Dhand A, Crum K, Hanken KE, Bhatkhande G, Luo M, Corbin IM, Usmanov G, Rothfeld-Wehrwein Z, Dhongade V, Lin D, Slocum C, Haff N, Choudhry NK. Social network intervention to improve blood pressure control after stroke: The TEAMS-BP randomized clinical trial. Soc Sci Med. 2025 Sep;380:118231. doi: 10.1016/j.socscimed.2025.118231. Epub 2025 May 21.

Reference Type: DERIVED

PMID: 40414088 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30AG064199-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P000444

Identifier Type: -

Identifier Source: org_study_id