NCT05258890

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

February 17, 2022

Results QC Date

November 22, 2024

Last Update Submit

March 8, 2025

Conditions

Keywords

Social Networks

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure for Patient-Subjects

    Blood pressure was not collected for social network members.

    baseline and 3 months

Secondary Outcomes (2)

  • Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects

    3 months

  • Patient Reported Physical Function for Patient-Subjets

    3 months

Study Arms (2)

Social Network Counseling

EXPERIMENTAL

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

Individual Counseling

ACTIVE COMPARATOR

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

Interventions

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.

Social Network 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.

Individual Counseling

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ischemic StrokeHypertension

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Amar Dhand, MD, PhD
Organization
Brigham and Women's Hospital

Study Officials

  • Amar Dhand, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

May 31, 2022

Primary Completion

January 26, 2024

Study Completion

January 27, 2024

Last Updated

March 26, 2025

Results First Posted

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations