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The effect of mobile phone system on the control of hypertension: a randomized clinical trial

Grant number: 18/20948-2
Support type:Regular Research Grants
Duration: July 01, 2019 - June 30, 2021
Field of knowledge:Health Sciences - Nursing
Principal Investigator:Angela Maria Geraldo Pierin
Grantee:Angela Maria Geraldo Pierin
Home Institution: Escola de Enfermagem (EE). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Associated scholarship(s):19/17157-6 - The effect of mobile phone system on the control of hypertension: a randomized clinical trial, BP.TT

Abstract

Background: Blood pressure control in hypertensive patients is a persistent public health problem and requires new strategies from healthcare providers to face it. Studies around the world had positive results from strategies using technologies and sending messages through the cell phone can be a resource to maximize adherence to treatment and consequently controlling blood pressure. Further, there are few studies that add to this strategy the evaluation of adherence by checking serum antihypertensive drugs levels. Objective: To Compare the effect of an intervention trough sending text messages by mobile phone and usual care, among hypertensive patients undergoing outpatient treatment. Methods: It is a randomized clinical trial that will be performed at the Hypertension Ambulatory of the Hospital das Clínicas of University of São Paulo Medical School. The inclusion criteria are: patients >18 years old, diagnosed with hypertension, uncontrolled blood pressure, having cell phone, Mini-Mental State Examination score consistent with schooling, and written consent. The exclusion criteria are: patients >65 years old, diagnosed as having secondary hypertension, pregnant women, systolic blood pressure > 180 mmHg and diastolic blood pressure > 110 mmHg, glomerular filtration rate <30 ml/min and Body Mass Index > 40 kg/m². Each group will consist of 120 participants. The hypertensive participants of the intervention will receive text messages about hypertension and treatment, type SMS, twice a week, for 10 weeks. The hypertensive patients in the control group will receive the usual care already performed at the institution. Both groups will receive the recommended basic treatment, including guidelines about the disease and treatment from the study nurse, and the provision of educational pamphlet. The following assessment will be performed at the beginning and at the end of the study, as follows: on the baseline assessment, all participants will be interviewed for biopsychosocial data collection; habits and lifestyles; comorbidities; drugs in use and assessment of adherence to the treatment will be done by patient referred data and, also, by high-performance liquid chromatography-tandem mass spectrometry. Anthropometric evaluation; laboratory tests; measurements of office blood pressure with a validated automatic device and 24-h ambulatory blood pressure monitoring will also be performed. The primary endpoint consists in control of ambulatory blood pressure (<140 mmHg at systolic pressure and <90 mmHg at diastolic pressure); and by ambulatory blood pressure monitoring (ABPM) (<135 mmHg at systolic pressure and <85 mmHg at diastolic pressure). For analysis of the results, dispersion and central dispersion tests, Pearson's Ç2 test, Fisher's exact test, Mann-Whitney, Wilcoxon-Mann-Whitney will be used. (AU)