Telehealth for managing blood pressure after stroke
Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)
This study is testing two different ways to help stroke survivors manage their blood pressure better, one in-person at a clinic and the other through telehealth, to see which works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06247254 on ClinicalTrials.gov |
What this trial studies
This trial evaluates two comprehensive strategies for managing blood pressure in stroke patients: Intensive Clinic Management and Intensive Tailored Telehealth Management. It aims to address the high prevalence of hypertension among stroke survivors, which significantly increases the risk of recurrent strokes and cardiovascular events. The study is funded by the Patient-Centered Outcomes Research Institute and focuses on improving hypertension control through evidence-based approaches. By including diverse populations and emphasizing secondary prevention, the trial seeks to optimize patient care for those affected by stroke.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced an ischemic or hemorrhagic stroke and have a history of hypertension.
Not a fit: Patients who do not have a history of hypertension or who are not able to participate in telehealth due to lack of access to a smartphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes and improve overall cardiovascular health in stroke survivors.
How similar studies have performed: Other studies have shown success in managing hypertension through telehealth interventions, indicating a promising approach for this patient population.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 cellular connectivity * 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 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 * Mid upper arm circumference \> 45 cm/17.7 inches or \< 22 cm / 8.66 inches * Missing values for Systolic Blood Pressure or Patient Activation Measure (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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Cheryl Bushnell, MD — Wake Forest University Health Sciences
- Study coordinator: Cheryl Bushnell, MD
- Email: cbushnel@wakehealth.edu
- Phone: 336-713-7788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.