Hypertension Management Using Telemonitoring

NCT03700775 | Completed

• 1 other identifier: 2018-0012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

Hypertension; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• BP control rates

  12 months

• Antihypertensive medication adjustments

  6 months

Study Arms (1)

Telemonitoring intervention

EXPERIMENTAL

Other: Remote Telemonitoring

Interventions

Remote Telemonitoring 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.

Telemonitoring intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Singe center prospective cohort study

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: September 17, 2018
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)