Hypertension Management Using Telemonitoring

NCT ID: NCT03700775

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2020-06-22

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemonitoring intervention

Group Type: EXPERIMENTAL

Remote Telemonitoring

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

2018-0012

Identifier Type: -

Identifier Source: org_study_id