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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

A community-academic partnership composed of a State University of New York (SUNY) Downstate Health Sciences University inter-disciplinary team of scientists (representing public health, medical informatics, vascular neurology/stroke center) and the Digital Equity Community Advisory Board (DECA) will guide our research. This is an NIH R21 pilot study. Our Specific Aims are designed to inform the sample design and research priorities for a larger NIH R01 experimental study and to serve as a platform for similar studies with other health conditions. We propose a mixed-methods study design with the following aims: 1. Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist. 2. Conduct a 9-month pilot randomized control trial (RCT) of DESA in a Central Brooklyn stroke population to examine the feasibility and preliminary efficacy. 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 medication compliance. Our primary hypothesis is that patients randomized to the DESA will significantly reduce systolic blood pressure at 9 months. 3. Examine barriers and facilitators to the adoption and integration of DESA into routine stroke care utilizing key informant interviews and user satisfaction surveys with neurologists and intervention participants.

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 data supports the idea that Digital Stroke Care Platform for High Blood Pressure is an effective treatment?

The available research shows that digital health interventions, like the Digital Stroke Care Platform for High Blood Pressure, can improve patient adherence to medication and lifestyle changes, which are crucial for preventing stroke recurrence. One study highlights that digital technologies help patients stick to their treatment plans, reducing the chance of having another stroke. Another study suggests that these digital tools can make healthcare more accessible, especially for people who might not have easy access to traditional healthcare services. This is important because better access and adherence can lead to better health outcomes for stroke patients. ^{1 2 3 4 5}

What safety data exists for the Digital Stroke Care Platform for High Blood Pressure?

The provided research does not directly address safety data for the Digital Stroke Care Platform or DESA. However, it discusses the effectiveness and feasibility of digital health interventions for stroke prevention and management, including remote hypertension management and mobile technology for stroke risk awareness. These studies suggest that digital interventions can improve medication adherence and blood pressure control, but specific safety data for DESA is not mentioned. ^{2 4 5 6 7}

Is the Digital Stroke Care Platform a promising treatment for high blood pressure?

Yes, the Digital Stroke Care Platform is promising because it uses digital tools to make stroke care more accessible, especially for people who might not have easy access to healthcare. It helps in preventing strokes, detecting them quickly, and managing recovery. It also empowers patients to manage their health better by using mobile apps and other technologies. ^{3 8 9 10 11}

Research Team

Aimee Afable, PhD, MPH

Principal Investigator

SUNY Downstate Health Sciences University

David R Kaufman, PhD, FACMI

Principal Investigator

SUNY Downstate Health Sciences University

Eligibility Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

You have dementia.

I do not speak English.

You have severe depression or other serious mental health conditions.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Improving Patient-Reported Outcomes in Stroke Care using Remote Blood Pressure Monitoring and Telehealth. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Moving Towards Equity With Digital Health Innovations for Stroke Care. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Health Economic Evaluations of Digital Health Interventions for Secondary Prevention in Stroke Patients: A Systematic Review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A remote hypertension management program clinical algorithm. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Knowledge and perspectives of community members on risk assessment for stroke prevention using mobile health approaches in Nigeria. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Knowing Patients Better After a Stroke and Secondary Prevention. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Digital health in stroke medicine: what are the opportunities for stroke patients? [2021]

11. United States pubmed.ncbi.nlm.nih.gov

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial. [2019]