StrokeDESANCT06119152
Digital Equity for Stroke Approach
A study testing DESA in people with Stroke and Blood Pressure, High, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Blood Pressure, High
- What is being tested?
- DESA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American or Afro-Caribbean
- 18 years or over
- Experienced a stroke in the last 6 years
- A score between 2 and 4 on the Modified Rankin Scale2
- 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)
Who cannot join
- Mental illness (severe depression)
- dementia
- Non-English speakers
- aphasia
- severe dysarthria (slurred speech/impediment)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Hospital at Downstate
Brooklyn, New York, 11203
Steven Levine, MD, 718-270-3188, steven.levine@downstate.edu
Nadege Gilles, MPH, 718-270-7786, nadege.gilles@downstate.edu
About this study
Official title: Digital Equity for Stroke Approach Pilot Study
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:
- Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist.
- 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.
- 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.
- Conditions
- Stroke, Blood Pressure, High
- Being tested
- DESA
- Keywords
- Telehealth, Digital Health, Remote Device Monitoring, Health Disparities, Afro-Caribbean
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESABehavioural
Intervention group is monitored via remote bp monitoring and telehealth device.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| Intervention | Experimental | The DESA Intervention will use a telehealth device to help the patient take blood pressure daily, and monitor blood pressure management. Receives: Behavioral: DESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Change
Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily
Measured: 9 months
Secondary outcomes (2)
Number of Blood Pressure readings/week
Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily, so days measured are received from this.
Measured: 9 months
Medication Adherence
Measured by medication adherence survey, at beginning, midpoint, and endpoint of time frame.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start17 Oct 2023
- Primary completion17 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Kaufman, PhD, FACMI, Principal investigator, SUNY Downstate Health Sciences UniversityAimee Afable, PhD, MPH, Principal investigator, SUNY Downstate Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119152
- Sponsor's protocol ID
- 1849255-4
- Acronym
- DESA
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Equity for Stroke Approach Pilot Study
- ClinicalTrials.gov ID
- NCT06119152
- Acronym / sponsor ID
- DESA / 1849255-4
- Conditions
- Stroke, Blood Pressure, High
- Keywords
- Telehealth, Digital Health, Remote Device Monitoring, Health Disparities, Afro-Caribbean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 17 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| Intervention | Experimental | Behavioral: DESAThe DESA Intervention will use a telehealth device to help the patient take blood pressure daily, and monitor blood pressure management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- African American or Afro-Caribbean
- 18 years or over
- Experienced a stroke in the last 6 years
- A score between 2 and 4 on the Modified Rankin Scale2
- Has a formal or informal caregiver (e.g., relative, health aide or other) to assist them in activities of daily living
Key exclusion criteria (5 listed)
- Mental illness (severe depression)
- dementia
- Non-English speakers
- aphasia
- severe dysarthria (slurred speech/impediment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESAIntervention group is monitored via remote bp monitoring and telehealth device. | Behavioural | Intervention |
Primary outcome
Blood Pressure Change
Time frame: 9 months
Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily
2 secondary outcomes
Number of Blood Pressure readings/week
Time frame: 9 months
Medication Adherence
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Kaufman, PhD, FACMI principal investigator
SUNY Downstate Health Sciences University
Aimee Afable, PhD, MPH principal investigator
SUNY Downstate Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESA in people with Stroke and Blood Pressure, High, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimee Afable, PhD, Mph (718-270-6397, aimee.afable@downstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Change (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.