Hypertension Management Using Telemonitoring

Hypertension Clinical Trial

Official title:

Remote Hypertension Management Using Home Blood Pressure Telemonitoring and a Standardized Treatment Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700775
• Other study ID #: 2018-0012
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: June 22, 2020

Study information

• Verified date: July 2020
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Remote Telemonitoring
Using the telemedicine kit, participants will record a daily health session including 2 BP measurements obtained one minute apart. Participants are encouraged to record a health session every day, with a minimum of 5 days per week. Participants are also encouraged to equally divide health session recordings between the mornings and evenings. Every 2 weeks BP measurements will be assessed. If less than 75% of measurements are at goal <130/80 mmHg, the central Telehealth pharmacist will designate drug-therapy intensification according to an evidence-based treatment algorithm that is physician approved. Regardless of BP control, participants will be contacted by their nurse coordinator every 2 weeks. During all telephone visits nurse coordinators emphasize healthy lifestyle habits. Safety protocols are in place for dangerously high or low BP recordings.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	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.	6 months
Secondary	BP control rates	Number of participants with systolic BP <130 mmHg and diastolic BP <80 mmHg at the first clinic visit following completion of the protocol	12 months
Secondary	Antihypertensive medication adjustments	Quantify dose adjustments of existing medications and initiation of new medications	6 months