This clinical trial will evaluate a telemonitoring system for measuring blood pressure (BP) in the management of hypertension. The main outcome will be any hypertension-related side effects such as visits to the hospital, deaths, heart attacks or strokes during the 6-month trial. The study will be recruiting in Jackson, Mississippi, United States.
The details
Hypertension or high blood pressure (BP) is a common condition. If hypertension is not managed, it can lead to serious, life-threatening complications. These include heart attacks, stroke, and death. It can be difficult to manage BP levels long-term. Patients may need to change the dose or type of medication they are taking to manage BP.
It has been suggested that real-time monitoring of BP levels by a healthcare professional (HCP) could improve BP control.Telemonitoring is a system where a patient wears a BP monitor and BP readings are transmitted electronically to a database. A HCP such as a nurse or a doctor can review this information. Based on this, the HCP can recommend adjustments to medication or suggest lifestyle improvements.
This trial will evaluate a telemonitoring system for measuring blood pressure (BP) in patients with hypertension. The main outcomes evaluated will be any adverse events during the 6-month trial and blood pressure control.
Who are they looking for?
This trial will recruit 300 patients with hypertension. Patients must have had at least 2 clinic visits with BP greater than or equal to 140/90 mmHg in the past 12 months.
Patients with resistant hypertension cannot take part in the trial. Other exclusion criteria include chronic kidney disease, heart failure or recent history of heart attack (last 3 months). Pregnant female patients or women of childbearing age who refuse to use birth control during the study cannot participate. Patients with mental illnesses or with substance abuse problems will also be excluded.
How will it work
All participants will be assigned a telemedicine kit. Participants will record a daily health session including 2 BP measurements at least 5 days a week. BP measurements will be assessed by HCP every 2 weeks. If less than 75% of BP measurements are below 130/80 mmHg then the telemedicine pharmacist will adjust medication using a formula approved by the doctor. The nurse coordinator will also check in with patients every 2 weeks. Low or high BP recordings will trigger a safety protocol to ensure the safety of the participant. This study will last 6 months.
The main outcome will be any adverse event during the 6-month trial. The number of patients achieving good BP control and of drug dose changes will also be measured.
