Hypertension Management Using Telemonitoring

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Remote Telemonitoring

• Registration Number: NCT03700775
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

This is a prospective study evaluating the feasibility and safety of remote hypertension management using a central telemonitoring program among patients with elevated blood pressure (BP) at the University of Mississippi Medical Center (UMMC).

Detailed Description

Patients with elevated BP, identified by the electronic medical record, will be recruited for study enrollment. Patients will be mailed a telemonitoring kit including an electronic tablet equipped with a wireless BP cuff that transmits measurements directly to the UMMC electronic medical record and monitored by the UMMC Center for Telehealth. Patients will participate in a 6 month intervention period during which they will transmit daily BP recordings with regular contact by a Telehealth nurse coordinator who will provide education and encourage healthy lifestyle habits. Every 2 weeks BP medications will be adjusted according to an evidence-based treatment algorithm managed by the Center for Telehealth pharmacist using a standardized physician-approved protocol. Data analysis will track metrics of study enrollment, study completion, safety, therapeutic intensification, and BP change from baseline.

Study Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age greater than 18 years
2. Patient of UMMC clinician approving the study
3. At least 2 clinic encounters in the past 12 months with systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg

Exclusion Criteria

1. Stage 4 or 5 chronic kidney disease
2. Systolic heart failure (LVEF <50%) or major cardiovascular event (MI, stroke) within 3 months
3. Resistant hypertension (prescribed 3 or more antihypertensive medications at target doses) or known secondary cause of hypertension
4. Pregnancy or inability/unwillingness to use birth control for women of child-bearing potential
5. Institutionalized, dementia, limited life expectancy, uncontrolled mental illness, substance abuse, or other conditions that would prohibit ability to perform regular home BP monitoring

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemonitoring intervention	Remote Telemonitoring	-

Primary Outcome Measures

Name	Time	Method
Adverse events	6 months	Adverse event data will primarily be collected through self-report during each nursing coordinator contact with the patient. Participants will report any hospitalization longer than 12 hours, emergency room visits, or some-day clinic visits and reasons for those visits since the prior nurse coordinator encounter. Study staff will obtain and review medical records related to all adverse events including: deaths, hospitalizations, major cardiac events, incident kidney failure, and urgent evaluations for hypertension, hypotension, loss of consciousness or fainting, allergic reactions, hives, and angioedema. These events are evaluated for severity, expectedness, and potential relatedness to the intervention and study participation.

Secondary Outcome Measures

Name	Time	Method
BP control rates	12 months	Number of participants with systolic BP \<130 mmHg and diastolic BP \<80 mmHg at the first clinic visit following completion of the protocol
Antihypertensive medication adjustments	6 months	Quantify dose adjustments of existing medications and initiation of new medications

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States