TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure) (TEAMS-BP)
Primary Purpose
Stroke, Acute Ischemic, Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Group Counseling
Individual Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute Ischemic focused on measuring Social Networks
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Network Counseling
Individual Counseling
Arm Description
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.
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
Outcomes
Primary Outcome Measures
Change in Systolic Blood Pressure
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
This will be evaluated as achieving a blood pressure of <130/80
Patient reported physical function
This will be evaluated using the validated PROMIS questionnaire
Full Information
NCT ID
NCT05258890
First Posted
February 17, 2022
Last Updated
October 2, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05258890
Brief Title
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)
Acronym
TEAMS-BP
Official Title
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure): A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic, Hypertension
Keywords
Social Networks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Network Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual Counseling
Arm Type
Active Comparator
Arm Description
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
Intervention Type
Other
Intervention Name(s)
Social Network Group Counseling
Intervention Description
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
Intervention Name(s)
Individual Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure will be evaluated as an absolute reduction in systolic blood pressure at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Achievement of post-stroke hypertension treatment goal
Description
This will be evaluated as achieving a blood pressure of <130/80
Time Frame
3 months
Title
Patient reported physical function
Description
This will be evaluated using the validated PROMIS questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amar Dhand, MD, DPhil
Phone
617-732-5330
Email
adhand@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Niteesh Choudhry, MD, PhD
Phone
617-278-0930
Email
nkchoudhry@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amar Dhand, MD, DPhil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)
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