Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2 (Hyper2)

University of Sao Paulo General Hospital

Status: Active, not recruiting

Conditions: Heart Disease Risk Factors; Metabolic Cardiovascular Syndrome; Essential Hypertension

Treatments: Device: Using the Avatr App

Study type: Interventional

Funder types: Other

Identifiers

NCT05843682

5483/22/06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Stroke sequelae
2. Cognitive dysfunction

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Avatr

Other group

Description:

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.

Treatment:

Device: Using the Avatr App

Control

No Intervention group

Description:

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.