Clinical trial NCT05539443: Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
Official title: Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension Secondary
Keywords: Hypertension
Hypertension after stroke
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with 3-month SBP control
timeFrame: 3 months
Secondary outcomes:
measure: Mean change in systolic blood pressure (SBP) at 3 months
timeFrame: Baseline, 3 month
measure: Mean change in Partners in Health Scale (PIH) score at 3 months
timeFrame: Baseline, 3 month
measure: Proportion of participants eligible among those screened
timeFrame: 3 Month
measure: Proportion of participants providing written informed consent among those eligible
timeFrame: Baseline
measure: Proportion of participants attending both visits among those who are randomized in the study
timeFrame: 3 months
measure: Systolic Blood Pressure Mean Value
timeFrame: 3 months
measure: Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)
timeFrame: 3 months
measure: Proportion of participants billed
timeFrame: 3 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Cheryl Bushnell, MD
role: PRINCIPAL_INVESTIGATOR
References: