Trial Outcomes & Findings for TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure) (NCT NCT05258890)
NCT ID: NCT05258890
Last Updated: 2025-03-26
Results Overview
Blood pressure was not collected for social network members.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
baseline and 3 months
Results posted on
2025-03-26
Participant Flow
A total of 47 patients enrolled, but 2 patients withdrew prior to randomization. Social network members were only enrolled in the social network counseling arm. All consented patients' social network members were collected in the baseline questionnaire, prior to randomization. For patients who were randomized to individual counseling (n=21), network members were not enrolled. For patients who were randomized to social network counseling (n=24), network members were enrolled (n=17).
Participant milestones
| Measure |
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.
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 via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
21
|
|
Overall Study
Index Patients Who Started
|
24
|
21
|
|
Overall Study
Social Network Members Who Started Members
|
17
|
0
|
|
Overall Study
COMPLETED
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
22
|
10
|
Reasons for withdrawal
| Measure |
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.
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 via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Overall Study
Patient withdrawal
|
6
|
7
|
|
Overall Study
Patient lost to follow-up
|
10
|
3
|
|
Overall Study
Social network member withdrawal
|
1
|
0
|
|
Overall Study
Social network member lost to follow-up
|
5
|
0
|
Baseline Characteristics
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)
Baseline characteristics by cohort
| Measure |
Social Network Counseling - Patients Only
n=24 Participants
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.
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 - Patients Only
n=21 Participants
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Marital Status
Not married
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Marital Status
Married
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Social network size
|
4.92 Network members
STANDARD_DEVIATION 3.24 • n=5 Participants
|
5.86 Network members
STANDARD_DEVIATION 4.45 • n=7 Participants
|
5.36 Network members
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Age, Continuous
|
64.41 years
STANDARD_DEVIATION 13.46 • n=5 Participants
|
70.71 years
STANDARD_DEVIATION 10.41 • n=7 Participants
|
67.36 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity
Hisapnic/Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity
Not Hispanic/Latino
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Systolic Blood Pressure
|
135.32 mmHg
STANDARD_DEVIATION 21.74 • n=5 Participants
|
145.81 mmHg
STANDARD_DEVIATION 21.05 • n=7 Participants
|
140.44 mmHg
STANDARD_DEVIATION 21.55 • n=5 Participants
|
|
Education level
Some high school or less
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education level
High school graduate
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education level
Some college
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education level
Associate degree
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education level
Bachelor's degree
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education level
Graduate degree
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education level
Prefer not to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment status
Retired
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Employment status
Employed
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employment status
Self-employed
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Employment status
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 monthsBlood pressure was not collected for social network members.
Outcome measures
| Measure |
Social Network Counseling
n=24 Participants
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.
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
n=21 Participants
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure for Patient-Subjects
|
-10.82 mmHg
Standard Deviation 5.08
|
-5.31 mmHg
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This was only assessed for those patient subjects who completed the 3-month follow-up period.
This was evaluated as achieving a blood pressure of \<130/80 mmHg. Blood pressure was not collected for social network members.
Outcome measures
| Measure |
Social Network Counseling
n=8 Participants
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.
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
n=11 Participants
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This was only assessed for those patient-subjects who completed the 3-month follow-up period.
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.
Outcome measures
| Measure |
Social Network Counseling
n=8 Participants
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.
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
n=11 Participants
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Patient Reported Physical Function for Patient-Subjets
|
37.48 T-score on a scale
Standard Deviation 12.88
|
45.25 T-score on a scale
Standard Deviation 12.20
|
Adverse Events
Social Network Counseling
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Counseling
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Social Network Counseling
n=24 participants at risk
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.
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
n=21 participants at risk
The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
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.
|
|---|---|---|
|
Nervous system disorders
Acute/subacute ischemic stroke
|
0.00%
0/24 • Adverse events were collected from enrollment through the end of the 3 month study follow-up period.
Adverse events were only collected for patient-subjects. The social network members were enrolled as support for the enrolled index patient, and therefore, were not at risk of study-related adverse events since there was not an intervention targeting the social network members.
|
9.5%
2/21 • Adverse events were collected from enrollment through the end of the 3 month study follow-up period.
Adverse events were only collected for patient-subjects. The social network members were enrolled as support for the enrolled index patient, and therefore, were not at risk of study-related adverse events since there was not an intervention targeting the social network members.
|
|
Cardiac disorders
Planned surgery of carotid artery
|
4.2%
1/24 • Adverse events were collected from enrollment through the end of the 3 month study follow-up period.
Adverse events were only collected for patient-subjects. The social network members were enrolled as support for the enrolled index patient, and therefore, were not at risk of study-related adverse events since there was not an intervention targeting the social network members.
|
0.00%
0/21 • Adverse events were collected from enrollment through the end of the 3 month study follow-up period.
Adverse events were only collected for patient-subjects. The social network members were enrolled as support for the enrolled index patient, and therefore, were not at risk of study-related adverse events since there was not an intervention targeting the social network members.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place