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

Hypertension Clinical Trial

— TEAMS-BP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05258890
• Other study ID #: 2022P000444
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: January 27, 2024

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: January 27, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Achievement of post-stroke hypertension treatment goal	This will be evaluated as achieving a blood pressure of <130/80	3 months
Secondary	Patient reported physical function	This will be evaluated using the validated PROMIS questionnaire	3 months