Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

NCT05539443 | Completed DMC

• 2 other identifiers: IRB00085596PLACER-02020C3-21070
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension Secondary

Keywords

Hypertension; Hypertension after stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with 3-month SBP control

  3 months

Secondary Outcomes (8)

• 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

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

  3 months

Study Arms (2)

Intensive Clinic Management (ICM)

EXPERIMENTAL

Behavioral: Intensive Clinic Management (ICM)

Intensive tailored telehealth management (ITTM)

EXPERIMENTAL

Behavioral: Intensive tailored telehealth management (ITTM)

Interventions

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 Clinic Management (ICM)

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

Intensive tailored telehealth management (ITTM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cheryl Bushnell, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 14, 2022
• Study Start: October 11, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)