Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-02-29

Brief Summary

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The purpose of this study is to evaluate the effectiveness of the use of artificial intelligence in home monitoring in patients with uncontrolled arterial hypertension.

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Detailed Description

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Arterial hypertension (AH) is one of the most important cardiovascular risk factors, accounting for 13.5% of all deaths worldwide. Mobile health technologies have been applied as an important tool to improve patient engagement and blood pressure (BP) control, as an alternative approach to remote monitoring of hypertensive patients. Therefore, it is essential to help patients adopt healthy measures to assist in the daily control of BP.

As the barriers to therapeutic adherence are complex and varied, solutions to improve adherence at the population level should be multifactorial. Therefore, the use of an application elaborated by artificial intelligence adapted to individual needs and customs, can help in improving therapeutic adherence and provide better bp control in patients with uncontrolled hypertension.

Conditions

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Essential Hypertension Metabolic Cardiovascular Syndrome Heart Disease Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Avatr

In the inclusion visit, it will be install the Avatr App in the mobile device of the patients. The patients will give an evaluation to perform by the medical and nursing staff, where clinical data (office blood pressure, weight, height, abdominal circumference) will be collected and will answer questionnaires on quality of life, anxiety, sleep quality, food intake and therapeutic adherence. They will receive an automatic blood pressure measurement device to make household blood pressure measurement according to nursing guidance. Also, the patients will collected blood samples to further analysis for biochemical profile and 24-hour urine collection sample for urinary sodium dosage.

The patients will take four in person visits after the initial visit, with the final visit after 12 months.

Group Type OTHER

Using the Avatr App

Intervention Type DEVICE

The patients will use the mobile application called Avatr, which will monitor their health data, as well as provide individualized care and early intervention through alerts generated for the multidisciplinary team.

Control

The patients will perform the same initial evaluation and answer the same questionnaires as described above for the Intervention Group. In this evaluation they will receive guidance regarding the adoption of life habits by the multidisciplinary team. The Control Group will receive reinforcement of guidance only in face-to-face visits.

The patients will take four in person visits after the initial visit, with the final visit after 12 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Using the Avatr App

The patients will use the mobile application called Avatr, which will monitor their health data, as well as provide individualized care and early intervention through alerts generated for the multidisciplinary team.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Primary arterial hypertension in drug treatment with at least 3 classes of antihypertensive drugs in optimized dose
2. Aged between 20 and 65 years
3. Blood pressure of the office ≥ 140 and/or 90 mmHg
4. Facilities to use mobile and apps