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| ID | Type | Description | Link |
|---|---|---|---|
| PLACER-02020C3-21070 | Other Grant/Funding Number | PCORI |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Clinic Management (ICM) | Experimental |
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| Intensive tailored telehealth management (ITTM) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Clinic Management (ICM) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with 3-month SBP control | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 month |
| Mean change in Partners in Health Scale (PIH) score at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Bushnell, MD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2023 | Nov 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Intensive tailored telehealth management (ITTM) | Behavioral | A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial |
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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.
| Baseline, 3 month |
| Proportion of participants eligible among those screened | 3 Month |
| Proportion of participants providing written informed consent among those eligible | Baseline |
| Proportion of participants attending both visits among those who are randomized in the study | 3 months |
| Systolic Blood Pressure Mean Value | 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. | 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. | 3 months |