Hypertension SecondaryTEAMS-BPNCT05539443
Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
A study testing Intensive Clinic Management (ICM) and Intensive tailored telehealth management (ITTM) in people with Hypertension Secondary, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension Secondary
- What is being tested?
- Intensive Clinic Management (ICM) and Intensive tailored telehealth management (ITTM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- 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
- SBP>130 at the post-acute clinic visit (within 21 days of discharge) \& at Study Visit 1 (within 31 days of discharge)
- Able to read and understand English or Spanish
- Have access to a functioning smartphone or tablet with broadband access (required for the intervention)
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- Willing to install and use a study-compatible physical activity monitoring application on their smartphone or smartphone 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
- 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
- Transitioned to a facility such as skilled nursing or long-term care prior to enrollment
- 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
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke
Read the detailed description
The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).
- Conditions
- Hypertension Secondary
- Being tested
- Intensive Clinic Management (ICM), Intensive tailored telehealth management (ITTM)
- Keywords
- Hypertension, Hypertension after stroke
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Clinic Management (ICM)Behavioural
An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial
Intensive tailored telehealth management (ITTM)Behavioural
A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial
| Study group | Role | What they receive |
|---|---|---|
| Intensive Clinic Management (ICM) | Experimental | Not described Receives: Behavioral: Intensive Clinic Management (ICM) |
| Intensive tailored telehealth management (ITTM) | Experimental | Not described Receives: Behavioral: Intensive tailored telehealth management (ITTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with 3-month SBP control
Measured: 3 months
Secondary outcomes (8)
Mean change in systolic blood pressure (SBP) at 3 months
Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2).
Measured: Baseline, 3 month
Mean change in Partners in Health Scale (PIH) score at 3 months
Each of the 11 items on the PIH have eight response options ranging from (0) very good to (8) very poor. To calculate the total PIH score, the raw score is summed and transformed to a range [0,100], with lower PIH scores indicating higher patient activation.
Measured: Baseline, 3 month
Proportion of participants eligible among those screened
Measured: 3 Month
Proportion of participants providing written informed consent among those eligible
Measured: Baseline
Proportion of participants attending both visits among those who are randomized in the study
Measured: 3 months
Systolic Blood Pressure Mean Value
Measured: 3 months
Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)
The overall experience (Overall Rating) is rated on a 10-point scale from 0 (Worst) to 10 (Best). The top score is for overall score includes all participants that responded 9 or 10.
Measured: 3 months
Proportion of participants billed
Proportion of participants for which coaching or remote physiologic monitoring services were billed (at any point during the study) using Current Procedural Terminology (CPT) billing codes.
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 posted14 Sep 2022
- Study start11 Oct 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension SecondaryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 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 Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539443
- Sponsor's protocol ID
- IRB00085596
- Other IDs
- PLACER-02020C3-21070
- Acronym
- TEAMS-BP
- Status last verified
- Jul 2023
- First submitted
- 11 Aug 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
- ClinicalTrials.gov ID
- NCT05539443
- Acronym / sponsor ID
- TEAMS-BP / IRB00085596
- Conditions
- Hypertension Secondary
- Keywords
- Hypertension, Hypertension after stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Sep 2022 (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 multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke
Detailed description
The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Clinic Management (ICM) | Experimental | Behavioral: Intensive Clinic Management (ICM) |
| Intensive tailored telehealth management (ITTM) | Experimental | Behavioral: Intensive tailored telehealth management (ITTM) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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
- SBP>130 at the post-acute clinic visit (within 21 days of discharge) \& at Study Visit 1 (within 31 days of discharge)
- Able to read and understand English or Spanish
Key exclusion criteria (8 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 Management (ICM)An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial | Behavioural | Intensive Clinic Management (ICM) |
| Intensive tailored telehealth management (ITTM)A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial | Behavioural | Intensive tailored telehealth management (ITTM) |
Primary outcome
Proportion of participants with 3-month SBP control
Time frame: 3 months
8 secondary outcomes
Mean change in systolic blood pressure (SBP) at 3 months
Time frame: Baseline, 3 month
Mean change in Partners in Health Scale (PIH) score at 3 months
Time frame: Baseline, 3 month
Proportion of participants eligible among those screened
Time frame: 3 Month
Proportion of participants providing written informed consent among those eligible
Time frame: Baseline
Proportion of participants attending both visits among those who are randomized in the study
Time frame: 3 months
Systolic Blood Pressure Mean Value
Time frame: 3 months
Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)
Time frame: 3 months
Proportion of participants billed
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
Cheryl Bushnell, MD principal investigator
Wake Forest 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 (ICM) and Intensive tailored telehealth management (ITTM) in people with Hypertension Secondary, 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 10 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: finished, as of the sponsor's last update on 7 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with 3-month SBP control (time frame: 3 months). 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 7 Nov 2023.