An interventional study of Intensive Clinic Management (ICM) and Intensive tailored telehealth management (ITTM) in Hypertension Secondary, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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).
6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.
This study's enrollment of 74 is below the median of 90 across 4,996 interventional studies indexed under Hypertension.
Browse Hypertension studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Intensive Clinic Management (ICM)
Behavioral: Intensive tailored telehealth management (ITTM)
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
A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial
Proportion of participants with 3-month SBP control
Time frame: 3 months
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).
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences