University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
NCT Number: NCT03700775
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jackson, Mississippi, 39216, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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
Time frame: 6 months
Quantify dose adjustments of existing medications and initiation of new medications
University of Mississippi Medical Center
Other
Remote Hypertension Management Using Home Blood Pressure Telemonitoring and a Standardized Treatment Protocol
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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