Blood PressureTEAMS-BPNCT06247254
Telehealth-Enhanced Assessment and Management
A study testing Intensive Clinic Management and Intensive Tailored Telehealth Management in people with Blood Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Intensive Clinic Management and Intensive Tailored Telehealth Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging [MRI]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting > 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI
- Age ≥18 years
- Discharged directly home from acute care or inpatient rehabilitation
- At least one of the following: documented history of hypertension; self-reported history of hypertension; use of
- hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)
- Systolic Blood Pressure ≥ 130 mmHg
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- Able to read and understand English or Spanish,
- Have access to a functioning smartphone or tablet with cellular connectivity
- Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet of a qualifying caregiver
- Stated agreement to participate in either intervention to which they are assigned and attend all required study visits,
- Consent to receiving Short Message Service (SMS) required as part of the study interventions
- Consent to enrollment in Chronic Care Management required as part of the study interventions,
- Provision of a signed and dated informed consent form
Who cannot join
- Subdural hematoma or subarachnoid hemorrhage
- Current participation in another stroke clinical trial precluding dual enrollment
- Presence of terminal illness, such as cancer, that limits life expectancy to <1 year
- Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis
- Pregnancy, lactation or planning to become pregnant
- Late-stage Alzheimer's disease or related dementia
Show all 10Show fewer
- Transitioned to a facility such as skilled nursing or long-term care prior to enrollment
- Mid upper arm circumference > 45 cm/17.7 inches or < 22 cm / 8.66 inches
- Missing values for Systolic Blood Pressure or Patient Activation Measure (PAM) score at baseline
- Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)
TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.
Read the detailed description
Hypertension affects nearly half of the US population (46% of adults) and is the strongest risk factor for recurrent stroke. Prevalence in patients with ischemic or hemorrhagic stroke in the US varies by region (highest in the South) ranging from 70% to 82%, and is associated with greater risk of recurrent stroke, major cardiovascular events, and death. A vital question for stroke patients and caregivers is how to prevent a recurrent stroke and further adverse events. Multiple clinical trials have shown that lowering BP reduces the risk for cardiovascular disease and stroke. Few trials, however, included stroke patients with a focus on secondary prevention nor were representative of vulnerable populations. The former US Surgeon General recently published a Call to Action focused on BP with three goals: 1) make hypertension control a national priority; 2) ensure that communities support hypertension control; and 3) optimize patient care for hypertension control.
- Conditions
- Blood Pressure
- Being tested
- Intensive Clinic Management, Intensive Tailored Telehealth Management
- Keywords
- Hypertension, Stroke, Cardiovascular events
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Clinic ManagementBehavioural
Also called ICM
Blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., < 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs.
Intensive Tailored Telehealth ManagementBehavioural
Also called ITTM
Tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Tailored Telehealth Management (ITTM) | Experimental | ITTM is a novel adaptation of the Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink) model, based on the premise that patients have social and functional barriers to blood pressure management. In the ITTM arm, barriers to care are identified and addressed through Blood Pressure Care Plan messaging and referrals to needed resources. The ITTM intervention includes a tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. INTERVENT services may be reimbursed using Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) insurance billing codes. Blood pressure monitors and wearable physical activity trackers will be provided to participants as part of the study. Receives: Behavioral: Intensive Tailored Telehealth Management |
| Intensive Clinic Management (ICM) | Other | ICM is based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) model and includes blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., < 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs. Blood pressure monitors will be provided as part of the study. Receives: Behavioral: Intensive Clinic Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attaining the Target Systolic Blood Pressure of <130 mmHg
Systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols at 6 months (Study Visit 3).
Measured: Month 6
Secondary outcomes (3)
Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke
Defined as the systolic blood pressure at baseline (Visit 1) subtracted from the systolic blood pressure at 6 months (Visit 3). At both time points, systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols
Measured: Baseline to Month 6
Number of major adverse cardiovascular events (MACE)
Prevalence of major adverse cardiovascular events (MACE) - death or hospitalization from myocardial infarction, coronary heart disease, or stroke - within 1 year following randomization.
Measured: Month 12
Change in Patient Activation Measured with the Patient Activation Measure (PAM)
Defined as the PAM Score at baseline (Visit 1) subtracted from the PAM Score at 6 months (Visit 3). The PAM is a validated 13-item patient-reported outcome measure (PROM) that measures skills and confidence to self-manage chronic disease. Response options for the 13 items are disagree strongly, disagree, agree, agree strongly with an interval-level scale from 0 to 100. To obtain the total PAM score, a propriety scoring algorithm will be used, with higher PAM scores indicating higher patient activation. Change in PAM will be analyzed as a continuous variable.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Nov 2024
- Primary completion25 Feb 2026
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Bushnell, MD, Principal investigator, Wake Forest University Health SciencesWayne Rosamond, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247254
- Sponsor's protocol ID
- IRB00114353
- Other IDs
- 2020C3-21070
- Acronym
- TEAMS-BP
- Status last verified
- Dec 2025
- First submitted
- 22 Jan 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)
- ClinicalTrials.gov ID
- NCT06247254
- Acronym / sponsor ID
- TEAMS-BP / IRB00114353
- Conditions
- Blood Pressure
- Keywords
- Hypertension, Stroke, Cardiovascular events
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.
Detailed description
Hypertension affects nearly half of the US population (46% of adults) and is the strongest risk factor for recurrent stroke. Prevalence in patients with ischemic or hemorrhagic stroke in the US varies by region (highest in the South) ranging from 70% to 82%, and is associated with greater risk of recurrent stroke, major cardiovascular events, and death. A vital question for stroke patients and caregivers is how to prevent a recurrent stroke and further adverse events. Multiple clinical trials have shown that lowering BP reduces the risk for cardiovascular disease and stroke. Few trials, however, included stroke patients with a focus on secondary prevention nor were representative of vulnerable populations. The former US Surgeon General recently published a Call to Action focused on BP with three goals: 1) make hypertension control a national priority; 2) ensure that communities support hypertension control; and 3) optimize patient care for hypertension control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Tailored Telehealth Management (ITTM) | Experimental | Behavioral: Intensive Tailored Telehealth ManagementITTM is a novel adaptation of the Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink) model, based on the premise that patients have social and functional barriers to blood pressure management. In the ITTM arm, barriers to care are identified and addressed through Blood Pressure Care Plan messaging and referrals to needed resources. The ITTM intervention includes a tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. INTERVENT services may be reimbursed using Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) insurance billing codes. Blood pressure monitors and wearable physical activity trackers will be provided to participants as part of the study. |
| Intensive Clinic Management (ICM) | Other | Behavioral: Intensive Clinic ManagementICM is based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) model and includes blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., < 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs. Blood pressure monitors will be provided as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging [MRI]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting > 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI
- Age ≥18 years
- Discharged directly home from acute care or inpatient rehabilitation
- At least one of the following: documented history of hypertension; self-reported history of hypertension; use of
- hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)
Key exclusion criteria (10 listed)
- Subdural hematoma or subarachnoid hemorrhage
- Current participation in another stroke clinical trial precluding dual enrollment
- Presence of terminal illness, such as cancer, that limits life expectancy to <1 year
- Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis
- Pregnancy, lactation or planning to become pregnant
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 |
|---|---|---|
| Intensive Clinic ManagementAlso: ICMBlood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., < 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs. | Behavioural | Intensive Clinic Management (ICM) |
| Intensive Tailored Telehealth ManagementAlso: ITTMTailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. | Behavioural | Intensive Tailored Telehealth Management (ITTM) |
Primary outcome
Attaining the Target Systolic Blood Pressure of <130 mmHg
Time frame: Month 6
Systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols at 6 months (Study Visit 3).
3 secondary outcomes
Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke
Time frame: Baseline to Month 6
Number of major adverse cardiovascular events (MACE)
Time frame: Month 12
Change in Patient Activation Measured with the Patient Activation Measure (PAM)
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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Behavior
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.
Cheryl Bushnell, MD principal investigator
Wake Forest University Health Sciences
Wayne Rosamond, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Clinic Management and Intensive Tailored Telehealth Management in people with Blood Pressure, run by Wake Forest University Health Sciences 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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Attaining the Target Systolic Blood Pressure of <130 mmHg (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.