Blood PressureiTASCNCT05049109
Integrated Telehealth After Stroke Care
A study testing Integrated Telehealth After Stroke Care and Usual post-stroke follow-up care in people with Blood Pressure and Stroke, Ischemic, run by Columbia University at 1 site in United States.
Trial summary
In this pilot trial, the investigator will compare early post-stroke BP management using an integrated Telehealth After Stroke Care (iTASC), to usual care with a primary outcome of BP control defined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- Integrated Telehealth After Stroke Care and Usual post-stroke follow-up care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Jun 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
- 18 years or older
- have had a stroke and have high blood pressure
Who cannot join
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
In this pilot trial, the investigator will compare early post-stroke BP management using an integrated Telehealth After Stroke Care (iTASC), to usual care with a primary outcome of BP control defined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes.
As this is a preliminary trial with a small sample, estimates derived will be used to plan the subsequent larger confirmatory trial. Descriptive statistics will characterize the randomized patients completing surveys and outcome assessments. The study will evaluate the primary clinical outcome (BP <140/90 mmHg) 90 days post-discharge as a function of treatment and adjusted for from baseline BP. Change from baseline BP will also be assessed as an outcome. Change in activity level and duration, as well as trends in sedentary time will be compared between arms, and pre- and post-intervention with visual tailored infographics in the intervention arm. Moderating effects of demographics will also be evaluated. Decisions regarding the pursuit of a subsequent trial will use the primary outcome, and analysis of all other measures will be hypothesis generating.
Read the detailed description
Hypertension is the single most modifiable risk factor for prevention of secondary stroke. However, blood pressure (BP) remains poorly controlled after a stroke in up to 55% of survivors. Uncontrolled hypertension is associated with lack of support, low level of independence, poor medication adherence and limited self-efficacy. These barriers are compounded following stroke with limited access to outpatient care. Sedentary behavior prevalence after stroke is high in both inpatient and community settings. Addressing physical activity may be a simple strategy to help counter growing health concerns during the pandemic from social restrictions.
Pre-COVID, the investigator created TASC (Telehealth After Stroke Care), an interdisciplinary telehealth clinic inclusive of primary care, pharmacy, and stroke specialists to address complex post-acute transitions of care and improve BP control. However, BP monitoring alone at best has a modest impact on medication adherence and health behaviors. As telehealth services expand during the pandemic, there is greater incentivization to devise interventions that utilize remote care to foster effective self-management.
Improving health behaviors through remote monitoring and patient tailored feedback in an integrated post-acute stroke care model has not been studied. Integrated TASC (iTASC) is a telehealth intervention inclusive of interdisciplinary care and remote technology including BP monitoring and tracked activity, supplemented by infographics tailored with the patient's own data, to enhance BP control and drive health behavior modification.
In this proof-of-concept trial, the investigator will compare early post-stroke BP management among post-acute stroke patients at discharge randomized to the iTASC intervention or usual care (primary care and stroke physician follow up without remote monitoring) with a primary outcome of BP control defined by the mean 24-hr BP at 3 months.
- Conditions
- Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- Integrated Telehealth After Stroke Care, Usual post-stroke follow-up care
- Keywords
- Post-stroke BP management, BP control
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Telehealth After Stroke CareBehavioural
Also called iTASC
- 3 week and 8 week follow up visits with pharmacy through telehealth
Patients will provide home blood pressure monitoring kits at discharge for the first three months. The telemonitor that can send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Any blood pressure readings that are not within normal range will trigger an alert to be sent to study staff who will then follow up with the patient. A trained staff member will show the patient how to use the blood pressure monitor. Patients will be asked to take blood pressure at least 3 days per week and transmit the readings to study staff.
Patients will also be asked to wear an activity monitor starting at 4 weeks.
Usual post-stroke follow-up careBehavioural
Also called Standard of care practice
- 1-2 weeks follow up visit with primary care.
- 4-6 week and 12 week follow up visit with stroke practitioner
- At the end of the study, patients will be asked questions regarding their experience with the telehealth visits, health, medication taking and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Group X | Experimental | Patients who have had stroke and high blood pressure will participate in 5 telehealth visits, which will take place over 3 months. In addition, remote BP monitoring will be given. Receives: Behavioral: Integrated Telehealth After Stroke Care; Behavioral: Usual post-stroke follow-up care |
| Group Y | Active comparator | Patients who have had stroke and high blood pressure will participate in 3 visits with primary care and stroke practitioner. Receives: Behavioral: Usual post-stroke follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hr systolic blood pressure (SBP) through remote monitoring at 3 months
A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Patients will be asked to take blood pressure at least 3 days per week. The readings will be averaged to obtain the mean measurement.
Measured: 3 Months
Difference in systolic blood pressure (SBP) from baseline to 3 months
A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. This is designed to measure the change in SBP from baseline to 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Syeda Imama A. Naqvi, MD, Principal investigator, Assistant Professor of Neurology at the Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049109
- Sponsor's protocol ID
- AAAT7278
- Other IDs
- KL2TR001874
- Acronym
- iTASC
- Status last verified
- Jun 2024
- First submitted
- 3 Sep 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Telehealth After Stroke Care
- ClinicalTrials.gov ID
- NCT05049109
- Acronym / sponsor ID
- iTASC / AAAT7278
- Conditions
- Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
- Keywords
- Post-stroke BP management, BP control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Sep 2021 (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.
In this pilot trial, the investigator will compare early post-stroke BP management using an integrated Telehealth After Stroke Care (iTASC), to usual care with a primary outcome of BP control defined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes.
As this is a preliminary trial with a small sample, estimates derived will be used to plan the subsequent larger confirmatory trial. Descriptive statistics will characterize the randomized patients completing surveys and outcome assessments. The study will evaluate the primary clinical outcome (BP <140/90 mmHg) 90 days post-discharge as a function of treatment and adjusted for from baseline BP. Change from baseline BP will also be assessed as an outcome. Change in activity level and duration, as well as trends in sedentary time will be compared between arms, and pre- and post-intervention with visual tailored infographics in the intervention arm. Moderating effects of demographics will also be evaluated. Decisions regarding the pursuit of a subsequent trial will use the primary outcome, and analysis of all other measures will be hypothesis generating.
Detailed description
Hypertension is the single most modifiable risk factor for prevention of secondary stroke. However, blood pressure (BP) remains poorly controlled after a stroke in up to 55% of survivors. Uncontrolled hypertension is associated with lack of support, low level of independence, poor medication adherence and limited self-efficacy. These barriers are compounded following stroke with limited access to outpatient care. Sedentary behavior prevalence after stroke is high in both inpatient and community settings. Addressing physical activity may be a simple strategy to help counter growing health concerns during the pandemic from social restrictions.
Pre-COVID, the investigator created TASC (Telehealth After Stroke Care), an interdisciplinary telehealth clinic inclusive of primary care, pharmacy, and stroke specialists to address complex post-acute transitions of care and improve BP control. However, BP monitoring alone at best has a modest impact on medication adherence and health behaviors. As telehealth services expand during the pandemic, there is greater incentivization to devise interventions that utilize remote care to foster effective self-management.
Improving health behaviors through remote monitoring and patient tailored feedback in an integrated post-acute stroke care model has not been studied. Integrated TASC (iTASC) is a telehealth intervention inclusive of interdisciplinary care and remote technology including BP monitoring and tracked activity, supplemented by infographics tailored with the patient's own data, to enhance BP control and drive health behavior modification.
In this proof-of-concept trial, the investigator will compare early post-stroke BP management among post-acute stroke patients at discharge randomized to the iTASC intervention or usual care (primary care and stroke physician follow up without remote monitoring) with a primary outcome of BP control defined by the mean 24-hr BP at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group X | Experimental | Behavioral: Integrated Telehealth After Stroke Care, Behavioral: Usual post-stroke follow-up carePatients who have had stroke and high blood pressure will participate in 5 telehealth visits, which will take place over 3 months. In addition, remote BP monitoring will be given. |
| Group Y | Active comparator | Behavioral: Usual post-stroke follow-up carePatients who have had stroke and high blood pressure will participate in 3 visits with primary care and stroke practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- have had a stroke and have high blood pressure
Key exclusion criteria (1 listed)
- unable to provide informed consent
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 |
|---|---|---|
| Integrated Telehealth After Stroke CareAlso: iTASC• 3 week and 8 week follow up visits with pharmacy through telehealth Patients will provide home blood pressure monitoring kits at discharge for the first three months. The telemonitor that can send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Any blood pressure readings that are not within normal range will trigger an alert to be sent to study staff who will then follow up with the patient. A trained staff member will show the patient how to use the blood pressure monitor. Patients will be asked to take blood pressure at least 3 days per week and transmit the readings to study staff. Patients will also be asked to wear an activity monitor starting at 4 weeks. | Behavioural | Group X |
| Usual post-stroke follow-up careAlso: Standard of care practice* 1-2 weeks follow up visit with primary care. * 4-6 week and 12 week follow up visit with stroke practitioner * At the end of the study, patients will be asked questions regarding their experience with the telehealth visits, health, medication taking and quality of life | Behavioural | Group X, Group Y |
Primary outcome
Mean 24-hr systolic blood pressure (SBP) through remote monitoring at 3 months
Time frame: 3 Months
A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Patients will be asked to take blood pressure at least 3 days per week. The readings will be averaged to obtain the mean measurement.
Difference in systolic blood pressure (SBP) from baseline to 3 months
Time frame: Baseline and 3 months
A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. This is designed to measure the change in SBP from baseline to 3 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Syeda Imama A. Naqvi, MD principal investigator
Assistant Professor of Neurology at the Columbia 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 Integrated Telehealth After Stroke Care and Usual post-stroke follow-up care in people with Blood Pressure and Stroke, Ischemic, run by Columbia University 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Jun 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean 24-hr systolic blood pressure (SBP) through remote monitoring at 3 months (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 12 Jun 2024.