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Clinical Trials/NCT05539443
NCT05539443CompletedNot Applicable

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Wake Forest University Health Sciences2 sites in 1 country74 target enrollmentStarted: October 11, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
74
Locations
2
Primary Endpoint
Proportion of participants with 3-month SBP control
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Proportion of participants with 3-month SBP control

Time Frame: 3 months

Secondary Outcomes

  • 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)(3 months)
  • Proportion of participants billed(3 months)
  • Mean change in systolic blood pressure (SBP) at 3 months(Baseline, 3 month)
  • Mean change in Partners in Health Scale (PIH) score at 3 months(Baseline, 3 month)
  • Proportion of participants eligible among those screened(3 Month)
  • Proportion of participants providing written informed consent among those eligible(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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