HypertensionTRIONCT05000970
Telehealth Referral to Improve Outcomes
A study testing blood pressure cuff PLUS tablet and Telehealth Consult in people with Hypertension, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Emergency patients often have uncontrolled asymptomatic hypertension upon discharge from the emergency department. This 3-arm randomized controlled trial will evaluate the impact of nurse telehealth encounters and remote patient monitoring, using a software called Vital Tech, on blood pressure control and primary care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- blood pressure cuff PLUS tablet and Telehealth Consult
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to Apr 2024
- 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
- Age ≥ 18 years
- At least two* high blood pressure readings during ED visit
- Systolic (top #) ≥140, ≤180 AND/OR
- Diastolic (bottom #) ≥ 90, ≤120
- Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.
Who cannot join
- symptomatic hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Hospital Center Emergency Dept
New York, New York, 10029
About this study
Official title: Telehealth Referral to Improve Outcomes for Asymptomatic Hypertension in the Emergency Department
Emergency patients often have uncontrolled asymptomatic hypertension upon discharge from the emergency department. This 3-arm randomized controlled trial will evaluate the impact of nurse telehealth encounters and remote patient monitoring, using a software called Vital Tech, on blood pressure control and primary care engagement.
Read the detailed description
Emergency Department (ED) clinicians encounter patients with asymptomatic hypertension (HTN) on a daily basis but usually fail to intervene. This pilot study will determine the utility of a novel intervention: Telehealth Referral to Improve Outcomes (TRIO), a conceptually driven information technology tool focused on patients who are asymptomatic and hypertensive upon ED discharge. It is designed to successfully link them to a primary care provider (PCP) after ED discharge to improve blood pressure (BP) control. 48 adult ED patients who have asymptomatic HTN (BP >/= 140/90 mmg and </= 180/120 mmHg) and who will be discharged will be enrolled in the study. This study is a single-site, 3-arm randomized controlled pilot trial. All patients will receive a wireless BP monitor and tablet. Group 2 (N=16) will additionally receive a telehealth consult with an RN at day 3. Group 3 (N=16) will additionally receive a telehealth consult with an RN at day 3 and day 7. The research team will collect feasibility outcomes: (recruitment rate, retention rate, and attrition rate of patients enrolled in TRIO at 6-months and 12-months. The research team will evaluate BP control and engagement with primary care at 6-months and 12-months and compare between groups.
- Conditions
- Hypertension
- Being tested
- blood pressure cuff PLUS tablet, Telehealth Consult
- Keywords
- Asymptomatic hypertension, Referral, Telehealth, Remote patient monitoring, Emergency Department, blood pressure
- Medical subject headings
- Hypertension, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure cuff PLUS tabletDevice
Also called wireless BP monitor and tablet
all arms
Telehealth ConsultOther
Telehealth consult with an RN
| Study group | Role | What they receive |
|---|---|---|
| TRIO PLUS tablet and nurse at day 3 | Experimental | Virtual nurse encounter at 3 days Receives: Device: blood pressure cuff PLUS tablet; Other: Telehealth Consult |
| TRIO PLUS Tablet and nurse at day 3 and 7 | Experimental | Virtual nurse encounter at 3 days and 7 days Receives: Device: blood pressure cuff PLUS tablet; Other: Telehealth Consult |
| TRIO PLUS Group | Placebo comparator | No encounter Receives: Device: blood pressure cuff PLUS tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
recruitment rate of patients enrolled in TRIO at 6-months.
Measured: 6 months
Recruitment rate
recruitment rate of patients enrolled in TRIO at 12-months.
Measured: 12 months
Retention rate
retention rate of patients enrolled in TRIO at 6-months.
Measured: 6 months
Retention rate
retention rate of patients enrolled in TRIO at 12-months.
Measured: 12 months
Attrition rate
attrition rate of patients enrolled in TRIO at 6-months.
Measured: 6 months
Attrition rate
attrition rate of patients enrolled in TRIO at 12-months.
Measured: 12 months
Secondary outcomes (4)
Blood pressure
Measured: 6 months
Blood pressure
Measured: 12 months
Number of participant who had follow up care
Primary Care Engagement to be defined as having follow up care (yes/no) at 6 months
Measured: 6 months
Number of participant who had follow up care
Primary Care Engagement to be defined as having follow up care (yes/no) at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start12 Jul 2021
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- AT&T and Vital Tech
- Responsible party
- Principal investigator, Kimberly T Souffront, Icahn School of Medicine at Mount Sinai
- Investigators
- Kimberly Souffront, PhD, APRN, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000970
- Sponsor's protocol ID
- IRB 20-01947
- Acronym
- TRIO
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2021
- Last updated
- 1 May 2023
- Results posted
- No
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Referral to Improve Outcomes for Asymptomatic Hypertension in the Emergency Department
- ClinicalTrials.gov ID
- NCT05000970
- Acronym / sponsor ID
- TRIO / IRB 20-01947
- Conditions
- Hypertension
- Keywords
- Asymptomatic hypertension, Referral, Telehealth, Remote patient monitoring, Emergency Department, blood pressure
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: funding
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- AT&T and Vital Tech
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Aug 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.
Emergency patients often have uncontrolled asymptomatic hypertension upon discharge from the emergency department. This 3-arm randomized controlled trial will evaluate the impact of nurse telehealth encounters and remote patient monitoring, using a software called Vital Tech, on blood pressure control and primary care engagement.
Detailed description
Emergency Department (ED) clinicians encounter patients with asymptomatic hypertension (HTN) on a daily basis but usually fail to intervene. This pilot study will determine the utility of a novel intervention: Telehealth Referral to Improve Outcomes (TRIO), a conceptually driven information technology tool focused on patients who are asymptomatic and hypertensive upon ED discharge. It is designed to successfully link them to a primary care provider (PCP) after ED discharge to improve blood pressure (BP) control. 48 adult ED patients who have asymptomatic HTN (BP >/= 140/90 mmg and </= 180/120 mmHg) and who will be discharged will be enrolled in the study. This study is a single-site, 3-arm randomized controlled pilot trial. All patients will receive a wireless BP monitor and tablet. Group 2 (N=16) will additionally receive a telehealth consult with an RN at day 3. Group 3 (N=16) will additionally receive a telehealth consult with an RN at day 3 and day 7. The research team will collect feasibility outcomes: (recruitment rate, retention rate, and attrition rate of patients enrolled in TRIO at 6-months and 12-months. The research team will evaluate BP control and engagement with primary care at 6-months and 12-months and compare between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRIO PLUS tablet and nurse at day 3 | Experimental | Device: blood pressure cuff PLUS tablet, Other: Telehealth ConsultVirtual nurse encounter at 3 days |
| TRIO PLUS Tablet and nurse at day 3 and 7 | Experimental | Device: blood pressure cuff PLUS tablet, Other: Telehealth ConsultVirtual nurse encounter at 3 days and 7 days |
| TRIO PLUS Group | Placebo comparator | Device: blood pressure cuff PLUS tabletNo encounter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- At least two* high blood pressure readings during ED visit
- Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.
Key exclusion criteria (1 listed)
- symptomatic hypertension
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 |
|---|---|---|
| blood pressure cuff PLUS tabletAlso: wireless BP monitor and tabletall arms | Device | TRIO PLUS Group, TRIO PLUS Tablet and nurse at day 3 and 7, TRIO PLUS tablet and nurse at day 3 |
| Telehealth ConsultTelehealth consult with an RN | Other | TRIO PLUS Tablet and nurse at day 3 and 7, TRIO PLUS tablet and nurse at day 3 |
Primary outcome
Recruitment rate
Time frame: 6 months
recruitment rate of patients enrolled in TRIO at 6-months.
Recruitment rate
Time frame: 12 months
recruitment rate of patients enrolled in TRIO at 12-months.
Retention rate
Time frame: 6 months
retention rate of patients enrolled in TRIO at 6-months.
Retention rate
Time frame: 12 months
retention rate of patients enrolled in TRIO at 12-months.
Attrition rate
Time frame: 6 months
attrition rate of patients enrolled in TRIO at 6-months.
Attrition rate
Time frame: 12 months
attrition rate of patients enrolled in TRIO at 12-months.
4 secondary outcomes
Blood pressure
Time frame: 6 months
Blood pressure
Time frame: 12 months
Number of participant who had follow up care
Time frame: 6 months
Number of participant who had follow up care
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Kimberly Souffront, PhD, APRN principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure cuff PLUS tablet and Telehealth Consult in people with Hypertension, run by Icahn School of Medicine at Mount Sinai 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 5 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: paused, as of the sponsor's last update on 1 May 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. Some participants in this study may receive a placebo. 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?
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?
Recruitment rate (time frame: 6 months). The study lists 6 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 1 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.