Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension Secondary
• Interventions: Behavioral: Intensive tailored telehealth management (ITTM); Behavioral: Intensive Clinic Management (ICM)

• Registration Number: NCT05539443
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Study Start: 2022-10-11
• Status Verified: 2023-07
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive tailored telehealth management (ITTM)	Intensive tailored telehealth management (ITTM)	-
Intensive Clinic Management (ICM)	Intensive Clinic Management (ICM)	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with 3-month SBP control	3 months

Secondary Outcome Measures

Name	Time	Method
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	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.
Proportion of participants billed	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.
Mean change in systolic blood pressure (SBP) at 3 months	Baseline, 3 month	Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2).
Mean change in Partners in Health Scale (PIH) score at 3 months	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.
Proportion of participants eligible among those screened	3 Month
Proportion of participants providing written informed consent among those eligible	Baseline

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States