TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)
- Conditions
- Stroke, Acute IschemicHypertension
- Interventions
- Other: Social Network Group CounselingOther: Individual Counseling
- Registration Number
- NCT05258890
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Social Network Counseling Social Network Group 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. Individual Counseling 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.
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure for Patient-Subjects baseline and 3 months Blood pressure was not collected for social network members.
- Secondary Outcome Measures
Name Time Method Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects 3 months This was evaluated as achieving a blood pressure of \<130/80 mmHg. Blood pressure was not collected for social network members.
Patient Reported Physical Function for Patient-Subjets 3 months This was evaluated for patient-subjects only (not collected for social network subjects), using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) scale.
For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.
The T-score is provided with an error term (Standard Error or SE). The Standard Error is a statistical measure of variance and represents the "margin of error" for the T-score.
A higher PROMIS T-score represents better physical function. A T-score of 60 indicates one SD better than the average physical function for the United States general population.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States