StrokeTASCNCT04640519
Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care
A study testing TASC intervention in people with Stroke and Health Care Acceptability, run by Columbia University at 1 site in United States.
Trial summary
The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Health Care Acceptability, Hypertension
- What is being tested?
- TASC intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 29 Jul 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
- Plan for discharge home after stroke
- Ability to provide consent (patient or caregiver)
Who cannot join
- Modified Rankin scale ≥ 4 at time of enrollment (severely disabled)
- Pregnancy
- Severe psychiatric illness
- Dialysis or diagnosis of end stage renal disease
- Life expectancy < 1 year or terminal illness
- Symptomatic flow limiting cerebrovascular stenosis without plan for intervention, or long-term BP goal ≥ 140/90
Trial locations and contacts
1 site in 1 country.
United States1 site
The Neurological Institute of New York, Columbia University
New York, New York, 10032
About this study
Official title: Telehealth After Stroke Care (TASC): Integrated Multidisciplinary Access to Post-stroke Care
The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.
Read the detailed description
Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP <140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.
- Conditions
- Stroke, Health Care Acceptability, Hypertension
- Being tested
- Usual care, TASC intervention
- Keywords
- Telehealth, Blood Pressure (BP)
- Medical subject headings
- Stroke, Patient Acceptance of Health Care, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
TASC interventionOther
TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
| Study group | Role | What they receive |
|---|---|---|
| TASC Intervention | Experimental | TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. Receives: Other: TASC intervention |
| TASC Control | Active comparator | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Systolic BP Control
The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.
Measured: Up to 3 months
Percentage of Participants Who Completed at Least 1 Video Visit
This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.
Measured: 3 months
Secondary outcomes (1)
Medication Adherence Percentage
Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start20 Oct 2020
- Primary completion29 Jul 2021
- Study completion29 Jul 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multidisciplinary Team Nursing: transitions of care, motivational interview w/ tailored infographics Pharmacy: medication education, adherence and titration Physician: patient tailored risk factor control, post stroke complications Integrated Approach: Home BP monitoring with remote support, Telehealth visits by each discipline, Tailored BP infographics, Patient Reported Outcomes (PROs)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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
- Principal investigator, Imama A. Naqvi, Columbia University
- Investigators
- Imama Naqvi, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640519
- Sponsor's protocol ID
- AAAT2612
- Other IDs
- UL1TR001873
- Acronym
- TASC
- Status last verified
- Sep 2022
- First submitted
- 17 Nov 2020
- Last updated
- 3 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naqvi IA, Cheung YK, Strobino K, Li H, Tom SE, Husaini Z, Williams OA, Marshall RS, Arcia A, Kronish IM, Elkind MSV. TASC (Telehealth After Stroke Care): a study protocol for a randomized controlled feasibility trial of telehealth-enabled multidisciplinary stroke care in an underserved urban setting. Pilot Feasibility Stud. 2022 Apr 11;8(1):81. doi: 10.1186/s40814-022-01025-z.
PubMed 35410312Naqvi IA, Strobino K, Kuen Cheung Y, Li H, Schmitt K, Ferrara S, Tom SE, Arcia A, Williams OA, Kronish IM, Elkind MSV. Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting. Stroke. 2022 Dec;53(12):3538-3547. doi: 10.1161/STROKEAHA.122.041020. Epub 2022 Oct 31.
PubMed 36314123
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth After Stroke Care (TASC): Integrated Multidisciplinary Access to Post-stroke Care
- ClinicalTrials.gov ID
- NCT04640519
- Acronym / sponsor ID
- TASC / AAAT2612
- Conditions
- Stroke, Health Care Acceptability, Hypertension
- Keywords
- Telehealth, Blood Pressure (BP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 3 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.
Detailed description
Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP <140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multidisciplinary Team Nursing: transitions of care, motivational interview w/ tailored infographics Pharmacy: medication education, adherence and titration Physician: patient tailored risk factor control, post stroke complications Integrated Approach: Home BP monitoring with remote support, Telehealth visits by each discipline, Tailored BP infographics, Patient Reported Outcomes (PROs)
| Arm | Type | Receives |
|---|---|---|
| TASC Intervention | Experimental | Other: TASC interventionTASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
| TASC Control | Active comparator | Other: Usual careUsual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
- Plan for discharge home after stroke
- Ability to provide consent (patient or caregiver)
Key exclusion criteria (6 listed)
- Modified Rankin scale ≥ 4 at time of enrollment (severely disabled)
- Pregnancy
- Severe psychiatric illness
- Dialysis or diagnosis of end stage renal disease
- Life expectancy < 1 year or terminal illness
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 |
|---|---|---|
| Usual careUsual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. | Other | TASC Control |
| TASC interventionTASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. | Other | TASC Intervention |
Primary outcome
Percentage of Participants With Systolic BP Control
Time frame: Up to 3 months
The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.
Percentage of Participants Who Completed at Least 1 Video Visit
Time frame: 3 months
This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.
1 secondary outcome
Medication Adherence Percentage
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35410312Naqvi IA, Cheung YK, Strobino K, Li H, Tom SE, Husaini Z, Williams OA, Marshall RS, Arcia A, Kronish IM, Elkind MSV. TASC (Telehealth After Stroke Care): a study protocol for a randomized controlled feasibility trial of telehealth-enabled multidisciplinary stroke care in an underserved urban setting. Pilot Feasibility Stud. 2022 Apr 11;8(1):81. doi: 10.1186/s40814-022-01025-z.
- Derived from this study: PubMed 36314123Naqvi IA, Strobino K, Kuen Cheung Y, Li H, Schmitt K, Ferrara S, Tom SE, Arcia A, Williams OA, Kronish IM, Elkind MSV. Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting. Stroke. 2022 Dec;53(12):3538-3547. doi: 10.1161/STROKEAHA.122.041020. Epub 2022 Oct 31.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Imama Naqvi, MD principal investigator
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 TASC intervention in people with Stroke and Health Care Acceptability, 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 3 inclusion and 6 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 3 Oct 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 3 Oct 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?
Percentage of Participants With Systolic BP Control (time frame: Up to 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?
On the ClinicalTrials.gov record for NCT04640519, which also lists 2 linked publications.
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 3 Oct 2022.