An interventional study of blood pressure cuff PLUS tablet and Telehealth Consult in Hypertension, sponsored by Icahn School of Medicine at Mount Sinai. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Prevention
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 773 studies on the registry; 176 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 83 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least two* high blood pressure readings during ED visit
Diastolic (bottom #) ≥ 90, ≤120
*Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.
Exclusion Criteria:
Virtual nurse encounter at 3 days
Device: blood pressure cuff PLUS tablet · Other: Telehealth Consult
Virtual nurse encounter at 3 days and 7 days
Device: blood pressure cuff PLUS tablet · Other: Telehealth Consult
No encounter
Device: blood pressure cuff PLUS tablet
all arms
Also known as: wireless BP monitor and tablet
Telehealth consult with an RN
Recruitment rate
recruitment rate of patients enrolled in TRIO at 6-months.
Time frame: 6 months
Recruitment rate
recruitment rate of patients enrolled in TRIO at 12-months.
Time frame: 12 months
Retention rate
retention rate of patients enrolled in TRIO at 6-months.
Time frame: 6 months
Retention rate
retention rate of patients enrolled in TRIO at 12-months.
Time frame: 12 months
Attrition rate
attrition rate of patients enrolled in TRIO at 6-months.
Time frame: 6 months
Attrition rate
attrition rate of patients enrolled in TRIO at 12-months.
Time frame: 12 months
Blood pressure
Time frame: 6 months
Blood pressure
Time frame: 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
Time frame: 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
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai →