RECRUITING

Telehealth-Enhanced Assessment and Management

Conditions

Blood Pressure Hypertension Stroke Cardiovascular events

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.

Official Title

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

Quick Facts

Study Start:2024-11-15

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06247254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * At least one of the following: documented history of hypertension; self-reported history of hypertension; use of * hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge) * Systolic Blood Pressure ≥ 130 mmHg * Able to read and understand English or Spanish, * Have access to a functioning smartphone or tablet with broadband access * Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet 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 * Consent to enrollment in Chronic Care Management required as part of the study interventions, * Provision of a signed and dated informed consent form	* 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 * Mid upper arm circumference \> 45 cm/17.7 inches or \< 22 cm / 8.66 inches * Missing values for Systolic Blood Pressure or Privileged Access Management (PAM) score at baseline * Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial

Inclusion Criteria

Exclusion 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
* At least one of the following: documented history of hypertension; self-reported history of hypertension; use of
* hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)
* Systolic Blood Pressure ≥ 130 mmHg
* Able to read and understand English or Spanish,
* Have access to a functioning smartphone or tablet with broadband access
* Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet 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
* Consent to enrollment in Chronic Care Management required as part of the study interventions,
* Provision of a signed and dated informed consent form

* 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
* Mid upper arm circumference \> 45 cm/17.7 inches or \< 22 cm / 8.66 inches
* Missing values for Systolic Blood Pressure or Privileged Access Management (PAM) score at baseline
* Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial

Contacts and Locations

Study Contact

Cheryl Bushnell, MD

CONTACT

336-713-7788

cbushnel@wakehealth.edu

Kelsey Shore

CONTACT

336-713-2739

kmshore@wakehealth.edu

Principal Investigator

Cheryl Bushnell, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Wayne Rosamond, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Cheryl Bushnell, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences
Wayne Rosamond, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15

Study Completion Date2028-07

Study Record Updates

Study Start Date2024-11-15

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

Hypertension
Stroke
Cardiovascular events

Additional Relevant MeSH Terms

Blood Pressure