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OpenTrials
Completed

NCT Number: NCT05539443

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Proportion of participants with 3-month SBP control

    Time frame: 3 months

Secondary outcomes

  1. Mean change in systolic blood pressure (SBP) at 3 months

    Time frame: Baseline, 3 month

    Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2).

  2. Mean change in Partners in Health Scale (PIH) score at 3 months

    Time frame: Baseline, 3 month

    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.

  3. Proportion of participants eligible among those screened

    Time frame: 3 Month

  4. Proportion of participants providing written informed consent among those eligible

    Time frame: Baseline

  5. Proportion of participants attending both visits among those who are randomized in the study

    Time frame: 3 months

  6. Systolic Blood Pressure Mean Value

    Time frame: 3 months

  7. Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)

    Time frame: 3 months

    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.

  8. Proportion of participants billed

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: TEAMS-BP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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