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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG064199-03 | U.S. NIH Grant/Contract | View source |
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Slow recruitment and poor retention despite several efforts to overcome these hurdles
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Network Counseling | Experimental | 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 | Active Comparator | The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Network Group Counseling | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure for Patient-Subjects | Blood pressure was not collected for social network members. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects | This was evaluated as achieving a blood pressure of <130/80 mmHg. Blood pressure was not collected for social network members. | 3 months |
| Patient Reported Physical Function for Patient-Subjets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amar Dhand, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40414088 | Derived | Dhand A, Crum K, Hanken KE, Bhatkhande G, Luo M, Corbin IM, Usmanov G, Rothfeld-Wehrwein Z, Dhongade V, Lin D, Slocum C, Haff N, Choudhry NK. Social network intervention to improve blood pressure control after stroke: The TEAMS-BP randomized clinical trial. Soc Sci Med. 2025 Sep;380:118231. doi: 10.1016/j.socscimed.2025.118231. Epub 2025 May 21. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics were not collected for social network members.
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| ID | Title | Description |
|---|---|---|
| BG000 | Social Network Counseling - Patients Only | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure for Patient-Subjects | Blood pressure was not collected for social network members. | Posted | Mean | Standard Deviation | mmHg | baseline and 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute/subacute ischemic stroke | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amar Dhand, MD, PhD | Brigham and Women's Hospital | 617-732-7432 | adhand@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2024 | Nov 14, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2023 | May 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Individual Counseling | Other | 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. |
|
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. |
| 3 months |
| Social network member withdrawal |
|
| Social network member lost to follow-up |
|
| BG001 | Individual Counseling - Patients Only | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Ethnicity | Count of Participants | Participants |
|
| Baseline Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Education level | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Social network size | Mean | Standard Deviation | Network members |
|
| OG001 | 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. |
|
|
| Secondary | Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects | This was evaluated as achieving a blood pressure of <130/80 mmHg. Blood pressure was not collected for social network members. | This was only assessed for those patient subjects who completed the 3-month follow-up period. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Patient Reported Physical Function for Patient-Subjets | 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. | This was only assessed for those patient-subjects who completed the 3-month follow-up period. | Posted | Mean | Standard Deviation | T-score on a scale | 3 months |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 21 | 2 | 21 | 0 | 21 |
| Planned surgery of carotid artery | Cardiac disorders | Non-systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |