Stroke, Acute IschemicTEAMS-BPNCT05258890
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)
A study testing Social Network Group Counseling and Individual Counseling in people with Stroke, Acute Ischemic and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Acute Ischemic, Hypertension
- What is being tested?
- Social Network Group Counseling and Individual Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure): A Randomized Control Trial
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.
- Conditions
- Stroke, Acute Ischemic, Hypertension
- Being tested
- Social Network Group Counseling, Individual Counseling
- Keywords
- Social Networks
- Medical subject headings
- Ischemic Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network Group CounselingOther
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 CounselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Social Network Group Counseling |
| 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. Receives: Other: Individual Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure for Patient-Subjects
Blood pressure was not collected for social network members.
Measured: baseline and 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start31 May 2022
- Primary completion26 Jan 2024
- Study completion27 Jan 2024
Why it stopped: Slow recruitment and poor retention despite several efforts to overcome these hurdles
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amar Dhand, MD DPhil, Brigham and Women's Hospital
- Investigators
- Amar Dhand, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258890
- Sponsor's protocol ID
- 2022P000444
- Other IDs
- 5P30AG064199-03
- Acronym
- TEAMS-BP
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40414088
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05258890
- Acronym / sponsor ID
- TEAMS-BP / 2022P000444
- Conditions
- Stroke, Acute Ischemic, Hypertension
- Keywords
- Social Networks
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and poor retention despite several efforts to overcome these hurdles
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network Counseling | Experimental | Other: Social Network Group CounselingThe 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 | Other: Individual CounselingThe index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Network Group CounselingResearchers 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. | Other | Social Network Counseling |
| Individual CounselingThe 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. | Other | Individual Counseling |
Primary outcome
Change in Systolic Blood Pressure for Patient-Subjects
Time frame: baseline and 3 months
Blood pressure was not collected for social network members.
2 secondary outcomes
Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects
Time frame: 3 months
Patient Reported Physical Function for Patient-Subjets
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40414088Dhand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amar Dhand, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network Group Counseling and Individual Counseling in people with Stroke, Acute Ischemic and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure for Patient-Subjects (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.