Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)

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

Study Overview

• Status: Completed
• Conditions: Hypertension Secondary
• Intervention / Treatment: Behavioral: Intensive Clinic Management (ICM); Behavioral: Intensive tailored telehealth management (ITTM)

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Clinic Management (ICM)	Behavioral: Intensive Clinic Management (ICM); 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
Experimental: Intensive tailored telehealth management (ITTM)	Behavioral: Intensive tailored telehealth management (ITTM); A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with 3-month SBP control	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline, 3 month
Proportion of participants eligible among those screened		3 Month
Proportion of participants providing written informed consent among those eligible		Baseline
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)	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Cheryl Bushnell, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Hypertension after stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB00085596; PLACER-02020C3-21070 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No