Digital Stroke Care Platform for High Blood Pressure

(DESA Trial)

Overseen By Aimee Afable, PhD, Mph

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York - Downstate Medical Center

Disqualifiers: Severe depression, Dementia, Aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool designed to help manage high blood pressure in individuals who have experienced a stroke. It uses a telehealth device for daily blood pressure monitoring and aims to determine if this method can better control blood pressure and improve medication adherence. Participants will either use this new tool, the Digital Equity for Stroke Approach (DESA), or receive standard care for comparison. The trial targets adults who are African American or Afro-Caribbean, have had a stroke within the past six years, and are patients at the University Hospital of Brooklyn, with caregiver support. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stroke recovery care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on blood pressure control and medication compliance is a secondary outcome, it's possible that you may need to continue your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this digital stroke care platform is safe for high blood pressure management?

Research shows that digital health tools, like the Digital Stroke Care Platform (DESA), are generally safe for managing high blood pressure. A study that reviewed multiple studies found that mobile health technologies, such as phone and text reminders, can effectively lower blood pressure without causing significant side effects.

These digital methods aim to help patients manage their condition more easily, potentially leading to better health outcomes. However, as this is an NIH pilot study, the focus is on how well the system works and integrates into everyday care. Participants in similar studies reported handling the technology well, with no major problems.

While DESA is not yet FDA-approved for this specific use, the technology is based on methods that have shown promise in other research, suggesting it is reasonably safe. However, each participant's experience may differ. Always consult a healthcare provider to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DESA intervention because it introduces a digital approach to managing high blood pressure, specifically targeting post-stroke care. Unlike traditional treatments that often rely on in-person visits and medication adjustments, DESA leverages a telehealth device for daily blood pressure monitoring, allowing for real-time management and adjustments. This method not only empowers patients to actively participate in their care but also provides healthcare providers with continuous data, potentially leading to more precise and timely interventions. This digital platform could revolutionize how high blood pressure is managed after a stroke, offering a more personalized and proactive approach compared to standard care methods.

What evidence suggests that the DESA platform is effective for managing high blood pressure in stroke patients?

Research has shown that digital health tools can help lower blood pressure in people facing health challenges. One study found that these digital solutions improved health outcomes. In this trial, researchers are testing the DESA platform as an intervention to make stroke prevention and treatment more accessible, especially for underserved communities. Early findings suggest that tools like DESA effectively control blood pressure by enabling regular monitoring and management. This evidence indicates that digital platforms can be a helpful way to manage high blood pressure for those at risk of stroke. ^{1 4 5 6 7}

Who Is on the Research Team?

David R Kaufman, PhD, FACMI

Principal Investigator

SUNY Downstate Health Sciences University

Aimee Afable, PhD, MPH

Principal Investigator

SUNY Downstate Health Sciences University

Are You a Good Fit for This Trial?

This trial is for African American or Afro-Caribbean adults over 18 who've had a stroke within the last 6 years and have someone to help them daily. They must be patients at University Hospital of Brooklyn with mild to moderate disability from stroke but can't join if they have dementia, severe speech issues, major depression, aphasia, or don't speak English.

Inclusion Criteria

You are of African American or Afro-Caribbean descent.

Has a formal or informal caregiver (e.g., relative, health aide or other) to assist them in activities of daily living

Has a primary care physician at University Hospital of Brooklyn (UHB)

Exclusion Criteria

You have dementia.

You have severe depression or other serious mental health conditions.

I have difficulty with speaking or understanding language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Randomized Control Trial

Conduct a 9-month pilot randomized control trial (RCT) of DESA in a Central Brooklyn stroke population to examine the feasibility and preliminary efficacy.

9 months

Daily telehealth monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DESA

Trial Overview

The study tests 'DESA', a digital tool aimed at improving stroke care through telehealth sessions and better blood pressure management. It's a pilot study where participants are randomly assigned to either use DESA or receive usual care for 9 months to see how well it works.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The DESA Intervention will use a telehealth device to help the patient take blood pressure daily, and monitor blood pressure management.

Group II: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

State University of New York - Downstate Medical Center

Lead Sponsor

Trials

67

Recruited

12,100+

Published Research Related to This Trial

A survey of 486 adults in Nigeria revealed that 84% wanted to know their stroke risk, but only 29.6% had previously assessed it, indicating a significant gap in awareness and assessment.

Most participants (70%) expressed a strong interest in using a mobile health application to assess their stroke risk, highlighting the potential for digital tools in stroke prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and perspectives of community members on risk assessment for stroke prevention using mobile health approaches in Nigeria. Sarfo, FS., Obiako, R., Nichols, M., et al.[2023]

The study demonstrated that an m-Health technology-enabled, nurse-guided intervention improved blood pressure control among Ghanaian stroke patients, with 66.7% of participants achieving systolic BP <140 mm Hg compared to 46.7% in the control group, although this difference was not statistically significant (P=0.12).

Medication adherence was significantly better in the intervention group, with a medication possession ratio of 0.88 compared to 0.64 in the control group (P=0.03), suggesting that the intervention may enhance treatment compliance among stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial. Sarfo, F., Treiber, F., Gebregziabher, M., et al.[2019]

Remote interventions, such as telemedicine and mobile health (mHealth) technologies, significantly improve medication adherence in stroke patients, with a standardized mean difference of 0.49 based on a meta-analysis of 10 studies involving various patients.

These interventions not only enhance adherence but also lead to significant improvements in clinical outcomes, including lower blood pressure and cholesterol levels, indicating their potential effectiveness as part of stroke rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Remote Interventions to Improve Medication Adherence in Patients after Stroke: A Systematic Literature Review and Meta-Analysis. Choi, YYC., Fineberg, M., Kassavou, A.[2023]

Digital health tools are increasingly being integrated into stroke care, enhancing access to treatments like tissue plasminogen activator and thrombectomy during acute phases, and improving rehabilitation access post-stroke.

These technologies are designed to support both healthcare professionals and patients across all stages of stroke care, helping to overcome geographical barriers and improve treatment adherence at a low cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health in stroke medicine: what are the opportunities for stroke patients? Antonenko, K., Paciaroni, M., Sokolova, L., et al.[2021]

Digital health interventions have shown efficacy in improving adherence to lifestyle changes for secondary stroke prevention, but there is a significant lack of health economic evidence to support their implementation in daily practice.

A systematic review of 20 articles found no health economic outcomes related to digital health interventions for stroke prevention, highlighting the need for future research to include economic considerations in trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Economic Evaluations of Digital Health Interventions for Secondary Prevention in Stroke Patients: A Systematic Review. Valenzuela Espinoza, A., Steurbaut, S., Dupont, A., et al.[2023]

A remote hypertension management program was developed that uses home blood pressure monitoring and algorithmic care pathways, showing promise in helping patients achieve better blood pressure control.

The program involves non-licensed patient navigators working under the supervision of healthcare professionals, allowing for personalized medication adjustments based on patient-specific characteristics, which could enhance scalability and effectiveness in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. Nichols, H., Cannon, CP., Scirica, BM., et al.[2022]

The Stroke Riskometer App was tested in a pilot study with 50 participants to assess its feasibility in improving stroke awareness and modifying risk behaviors, showing good retention at 87%.

While the App group showed a slight improvement in cardiovascular health compared to the control group, the results were not statistically significant, indicating the need for a larger trial to fully evaluate its effectiveness in primary stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial. Krishnamurthi, R., Hale, L., Barker-Collo, S., et al.[2023]

The study demonstrated the feasibility of using an interactive web-based platform to collect patient-reported outcomes (PROs) in a Telehealth program for poststroke care, indicating that technology can enhance patient engagement and self-management.

Participants in the Telehealth After Stroke Care (TASC) program showed nominally lower depressive scores after 3 months compared to usual care, suggesting that remote blood pressure monitoring may positively impact psychological well-being, particularly in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Patient-Reported Outcomes in Stroke Care using Remote Blood Pressure Monitoring and Telehealth. Naqvi, IA., Strobino, K., Li, H., et al.[2023]

This pilot trial will assess the effectiveness of a nurse-led, m-Health technology intervention in improving blood pressure control among 60 Ghanaian stroke survivors within one month of their stroke, compared to standard care.

The intervention includes a pillbox, a Bluetooth-enabled blood pressure device, and motivational text messages, aiming to enhance medication adherence and BP monitoring over a 3-month period, with follow-ups to evaluate outcomes at 3, 6, and 9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial. Sarfo, FS., Treiber, F., Jenkins, C., et al.[2019]

The study emphasizes the importance of habits and lifestyles in managing cardiovascular risk, particularly for patients who have experienced a cerebrovascular accident (CVA), who are at high risk for subsequent events.

A new integrated system combining a mobile app, web app, and peripheral devices was developed to monitor patients' habits and empower them in managing their health, potentially improving secondary prevention of CVA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowing Patients Better After a Stroke and Secondary Prevention. Escobar-Rodríguez, GA., Pérez-Esteban, RJ., Pérez-León, FP., et al.[2019]

Digital health tools have the potential to significantly improve access to stroke prevention and treatment, especially for historically disadvantaged populations, following their accelerated integration during the COVID-19 pandemic.

Despite the promise of digital health innovations, underrepresented individuals face disparities that could limit their benefits, highlighting the need for health systems to address these challenges to ensure equitable access to stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving Towards Equity With Digital Health Innovations for Stroke Care. Verma, A., Towfighi, A., Brown, A., et al.[2023]

Citations

1.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06119152?keyword=%22Blood%20Pressure%2C%20High%22

San Mateo Clinical Trial Digital Equity for Stroke Approach

We will randomize 50 adults to DESA and 30 to usual care. The primary outcome will be BP control. Secondary outcomes include the number of BP measurements and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10867699/

Digital Health Interventions for Hypertension Management in ...

These findings suggest that digital health interventions are associated with improved BP levels in populations experiencing health disparities.

3.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.121.035307

Moving Towards Equity With Digital Health Innovations for ...

Digital health may provide a path towards more accessible stroke prevention and treatment, particularly for historically disadvantaged patient populations.

4.

phti.org

phti.org/announcement/new-report-highlights-digital-solutions-that-improve-hypertension-control/

New Report Highlights Digital Solutions That Improve ...

Independent evaluation from PHTI finds certain digital blood pressure management solutions can improve clinical outcomes, ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05937685

Study Details | NCT05937685 | Reducing Blood Pressure ...

The primary outcome will be change in systolic blood pressure (SBP) at 12 months.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8885852/

Moving Towards Equity in Digital Health and Stroke Care - PMC

One meta-analysis concluded that mHealth using telephone and SMS text reminders contributed to a significant reduction in systolic blood pressure among stroke ...

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2815070

Digital Health Interventions for Hypertension Management ...

This systematic review and meta-analysis characterizes digital health interventions for reducing hypertension and assesses the association ...