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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05258890

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Ischemic Hypertension	Other: Social Network Group Counseling Other: Individual Counseling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Systolic Blood Pressure [3 months]
Change in systolic blood pressure will be evaluated as an absolute reduction in systolic blood pressure at 3 months

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First acute ischemic stroke defined clinically with support from imaging if necessary
21 years of age or older
Within 7 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amar Dhand, MD DPhil, Associate Professor of Neurology, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05258890

Other Study ID Numbers:

2022P000444

First Posted:

Feb 28, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amar Dhand, MD DPhil, Associate Professor of Neurology, Brigham and Women's Hospital

Social Networks

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of Jul 5, 2022