Stroke PreventionSTOP-StrokeNCT03923790
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
A study testing Educational Packet, Phone call at 72 hours by discharge nurse navigator and Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge in people with Stroke Prevention and Blood Pressure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Prevention, Blood Pressure, Telemedicine
- What is being tested?
- Educational Packet, Phone call at 72 hours by discharge nurse navigator and Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ischemic and hemorrhagic stroke patients
- Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
- Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
- Plan to discharge home after stroke
- Ability to provide consent (patient or caregiver)
- Ability to communicate in English
Who cannot join
- modified Rankin scale > 4 at the time of enrollment (severe disability)
- life expectancy < 1 year or terminal illness,
- eGFR < 30 at time of discharge
- pregnancy
- symptomatic flow limiting carotid stenosis without plan for intervention
- urine toxicology positive for cocaine or methamphetamine or recent use
- long-term BP goal ≥ 130/80 mmHg according to clinical team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.
- Being tested
- Educational Packet, Phone call at 72 hours by discharge nurse navigator, Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge, Educational messages every other week, BP monitoring by QardioARM with periodic transmission of BP data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational PacketBehavioural
The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigatorBehavioural
Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
Telehealth visit at 7 days, 1 month, 3 months, and 5 months after dischargeBehavioural
A stroke prevention trained nurse practitioner or MD or social worker will review the participant's hospital records and depression, dietary, and sleep apnea screens,will reinforce the care plan based on patient-specific needs.They will counsel patients on salt reduction, the Mediterranean diet, and the importance of diet and exercise for stroke prevention.Along with the pharmacist they will also review the BP data to determine the need for medication adjustment and will discuss the side effects and interactions.The social worker will assess the need for medication assistance and other resources. The care plan will be shared with primary care providers (PCP)and patients will be referred to a PCP if they do not have one. The social worker will also will assist uninsured patients in applying for Texas County Indigent Care programs.
Educational messages every other weekBehavioural
The messages will be sent to the participants cellular phones and will contain one of the following: a reminder to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the pharmacist about medication adherence
BP monitoring by QardioARM with periodic transmission of BP dataDiagnostic test
Participants will be prompted to transmit BP logs through the telemonitoring device every 2 weeks until average BP is < 130/80, then monthly thereafter. Uncontrolled BP will prompt a call from the pharmacist to discuss medication adherence and the need for further titration.
| Study group | Role | What they receive |
|---|---|---|
| STOP model | Experimental | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. Receives: Behavioral: Educational Packet; Behavioral: Phone call at 72 hours by discharge nurse navigator; Behavioral: Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge; Behavioral: Educational messages every other week; Diagnostic Test: BP monitoring by QardioARM with periodic transmission of BP data |
| Usual Care | Active comparator | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. Receives: Behavioral: Educational Packet; Behavioral: Phone call at 72 hours by discharge nurse navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Ambulatory Systolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Measured: 6 months after enrollment
Secondary outcomes (6)
Daytime Ambulatory Diastolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Measured: 6 months
Night Time Ambulatory Systolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Measured: 6 months
Nighttime Diastolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Measured: 6 months
Body Mass Index(BMI)
BMI will be calculated from height and weight.
Measured: 6 months
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)
Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.
Measured: 6 months
Number of Participants With Acute Healthcare Utilization
Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start4 Mar 2019
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke PreventionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Anjail Z Sharrief, The University of Texas Health Science Center, Houston
- Investigators
- Anjail Sharrief, Principal investigator, The University Of Texas Health Science Center of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923790
- Sponsor's protocol ID
- HSC-MS-18-0925
- Acronym
- STOP-Stroke
- Status last verified
- Oct 2022
- First submitted
- 18 Apr 2019
- Last updated
- 9 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
- ClinicalTrials.gov ID
- NCT03923790
- Acronym / sponsor ID
- STOP-Stroke / HSC-MS-18-0925
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 9 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STOP model | Experimental | Behavioral: Educational Packet, Behavioral: Phone call at 72 hours by discharge nurse navigator, Behavioral: Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge, Behavioral: Educational messages every other week, Diagnostic Test: BP monitoring by QardioARM with periodic transmission of BP dataPharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. |
| Usual Care | Active comparator | Behavioral: Educational Packet, Behavioral: Phone call at 72 hours by discharge nurse navigatorPharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic and hemorrhagic stroke patients
- Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
- Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
- Plan to discharge home after stroke
- Ability to provide consent (patient or caregiver)
Key exclusion criteria (7 listed)
- modified Rankin scale > 4 at the time of enrollment (severe disability)
- life expectancy < 1 year or terminal illness,
- eGFR < 30 at time of discharge
- pregnancy
- symptomatic flow limiting carotid stenosis without plan for intervention
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 |
|---|---|---|
| Educational PacketThe patient will receive an educational packet. | Behavioural | STOP model, Usual Care |
| Phone call at 72 hours by discharge nurse navigatorPatients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments | Behavioural | STOP model, Usual Care |
| Telehealth visit at 7 days, 1 month, 3 months, and 5 months after dischargeA stroke prevention trained nurse practitioner or MD or social worker will review the participant's hospital records and depression, dietary, and sleep apnea screens,will reinforce the care plan based on patient-specific needs.They will counsel patients on salt reduction, the Mediterranean diet, and the importance of diet and exercise for stroke prevention.Along with the pharmacist they will also review the BP data to determine the need for medication adjustment and will discuss the side effects and interactions.The social worker will assess the need for medication assistance and other resources. The care plan will be shared with primary care providers (PCP)and patients will be referred to a PCP if they do not have one. The social worker will also will assist uninsured patients in applying for Texas County Indigent Care programs. | Behavioural | STOP model |
| Educational messages every other weekThe messages will be sent to the participants cellular phones and will contain one of the following: a reminder to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the pharmacist about medication adherence | Behavioural | STOP model |
| BP monitoring by QardioARM with periodic transmission of BP dataParticipants will be prompted to transmit BP logs through the telemonitoring device every 2 weeks until average BP is < 130/80, then monthly thereafter. Uncontrolled BP will prompt a call from the pharmacist to discuss medication adherence and the need for further titration. | Diagnostic test | STOP model |
Primary outcome
Daytime Ambulatory Systolic Blood Pressure
Time frame: 6 months after enrollment
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
6 secondary outcomes
Daytime Ambulatory Diastolic Blood Pressure
Time frame: 6 months
Night Time Ambulatory Systolic Blood Pressure
Time frame: 6 months
Nighttime Diastolic Blood Pressure
Time frame: 6 months
Body Mass Index(BMI)
Time frame: 6 months
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)
Time frame: 6 months
Number of Participants With Acute Healthcare Utilization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke Prevention
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
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Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
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.
Anjail Sharrief principal investigator
The University Of Texas Health Science Center of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Packet, Phone call at 72 hours by discharge nurse navigator and Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge in people with Stroke Prevention and Blood Pressure, run by The University of Texas Health Science Center, Houston 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 7 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: finished, as of the sponsor's last update on 9 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Ambulatory Systolic Blood Pressure (time frame: 6 months after enrollment). 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 9 Nov 2022.