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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05843682

Collaborator

InCor Heart Institute (Other)

100

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension Metabolic Cardiovascular Syndrome Heart Disease Risk Factors	Device: Using the Avatr App	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 7, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: 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.
No Intervention: 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.

Arm

Intervention/Treatment

Other: 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.

Device: 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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Blood pressure control [One year]
Using the Avatr application with daily medication reminders, the patient will remember to use them. This way, there will be better control of blood pressure at home. Initially, 24-hour Ambulatory Blood Pressure Monitoring (ABPM) will be performed using the Spacelabs® device for initial control and during the four-monthly consultations, the mean blood pressure will be evaluated from the determination of systolic (SBP) and diastolic (DBP ) ) measured by an automatic sphygmomanometer (Omron HBP 1100 ®), on the right upper limb, with the individual sitting down, after 10 minutes of rest.
Glycemic control [One year]
Diabetic patients will have a personalized dietary guidance and will measure their blood glucose daily with the glucometer, in order to control the baseline blood glucose value.
Change of out-of-hospital visits [One year]
Change of extra-hospital visits during the monitoring period

Secondary Outcome Measures

Patient engagement in treatment [One year]
To assess patient engagement, a structured questionnaire will be applied to verify the usability of the AVATR, as well as to obtain knowledge about how patients felt when using the application and the impact of this monitoring on their health.
Improvement in lifestyle [One year]
When performing daily physical activity after specialized evaluation and exercise prescription, with resistance and/or cardiovascular exercises, in addition to adhering to an adequate diet according to dietary guidelines, we can infer a reduction in weight (kg) and abdominal circumference (measurements in centimeter).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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