1550 Participants Needed

Telehealth vs Clinic Management for High Blood Pressure

(TEAMS-BP Trial)

CB
KS
Overseen ByKelsey Shore
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Hypertension medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is telehealth generally safe for managing high blood pressure?

Telemedicine, including telehealth services in intensive care units, has been shown to improve patient safety by providing specialized care and support, especially in remote areas. It helps ensure constant monitoring and quick response to changes in a patient's condition, which is crucial for safety.12345

How is the Intensive Tailored Telehealth Management treatment for high blood pressure different from other treatments?

Intensive Tailored Telehealth Management is unique because it combines telehealth technology with team-based care, allowing for real-time monitoring and communication between patients and healthcare providers, which can improve blood pressure control more effectively than traditional clinic visits.678910

What data supports the effectiveness of the treatment Intensive Tailored Telehealth Management for high blood pressure?

Research shows that telehealth in intensive care can improve the quality of care by ensuring adherence to best practice guidelines and improving process quality, which may lead to better patient recovery and long-term outcomes. This suggests that telehealth could be effective in managing high blood pressure by providing consistent monitoring and support.14111213

Who Is on the Research Team?

Cheryl D. Bushnell, MD | Wake Forest ...

Cheryl Bushnell, MD

Principal Investigator

Wake Forest University Health Sciences

WR

Wayne Rosamond, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is designed for individuals who have experienced a stroke and are now managing high blood pressure. Participants should be interested in using telehealth services or attending intensive clinic visits to manage their condition.

Inclusion Criteria

I have had a stroke confirmed by an MRI or CT scan.
Systolic Blood Pressure ≥ 130 mmHg
Able to read and understand English or Spanish
See 8 more

Exclusion Criteria

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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Intensive Tailored Telehealth Management or Intensive Clinic Management for blood pressure control

6 months
Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Bi-monthly visits (in-person or virtual)

Long-term follow-up

Participants are monitored for major adverse cardiovascular events and changes in cognitive function

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intensive Clinic Management
  • Intensive Tailored Telehealth Management
Trial Overview The TEAMS-BP study compares two approaches: one where patients receive intensive management at clinics, and another where they get tailored support through telehealth technology to control their blood pressure after a stroke.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Intensive Tailored Telehealth Management (ITTM)Experimental Treatment1 Intervention
Group II: Intensive Clinic Management (ICM)Experimental Treatment1 Intervention

Intensive Clinic Management is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Intensive Clinic Management for:
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Approved in European Union as Intensive Clinic Management for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Published Research Related to This Trial

Telemedicine has become essential in intensive care units (ICUs) to enhance patient safety and ensure constant monitoring, especially with limited staffing and high workloads.
Nurses play a crucial role in leveraging telemedicine technology to improve communication with physicians, which is vital for timely decision-making and achieving better clinical outcomes.
A new era in the ICU: the case for telemedicine.Yeo, W., Ahrens, SL., Wright, T.[2018]
Implementing collaborative patient care rounds in three intensive care units led to significant improvements in the consideration of key practice items related to patient care, particularly in areas like delirium prevention and device use, with eight out of thirteen items showing increased attention (p < 0.05).
Nursing participation in care rounds increased from 83.9% to 91.8%, and the verbalization of daily goals rose dramatically from 59.8% to 89.1% (p < 0.0001), indicating enhanced collaboration and communication among healthcare providers.
Benefits of collaborative patient care rounds in the intensive care unit.Chapman, LB., Kopp, KE., Petty, MG., et al.[2021]
A telemedical program significantly improved adherence to seven key quality indicators in intensive care units, enhancing aspects like sedation management and infection control, based on a study of 1463 patients across 12 ICU clusters in Germany.
The intervention led to substantial improvements in patient care processes, with adjusted odds ratios indicating strong effectiveness in areas such as ventilation and patient communication, although no difference was found in adherence to daily clinical visits.
Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial.Spies, CD., Paul, N., Adrion, C., et al.[2023]

Citations

A new era in the ICU: the case for telemedicine. [2018]
Benefits of collaborative patient care rounds in the intensive care unit. [2021]
Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial. [2023]
[Quality Management in Intensive Care Units]. [2019]
Telemedicine in the intensive care unit: A vehicle to improve quality of care? [2021]
Medication safety in a German telemedicine centre: Implementation of a telepharmaceutical expert consultation in addition to existing tele-intensive care unit services. [2020]
Telemedicine in the intensive care unit: state of the art. [2015]
Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation. [2018]
Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Cost-Effectiveness and Challenges of Implementing Intensive Blood Pressure Goals and Team-Based Care. [2020]
Clinical outcome and cost-effectiveness of a synchronous telehealth service for seniors and nonseniors with cardiovascular diseases: quasi-experimental study. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study. [2023]
How the Integration of Telehealth and Coordinated Care Approaches Impact Health Care Service Organization Structure and Ethos: Mixed Methods Study. [2022]
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