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

Essential Hypertension Clinical Trial

— Hyper2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05843682
• Other study ID #: 5483/22/06
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 29, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Heart Diseases
• Hypertension
• Metabolic Cardiovascular Syndrome
• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor), Hospital das Clinicas do HCFMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Dupont J, Dupont JC, Milon H, Froment A. [Spontaneous mortality and vascular lesions in 3 rat strains with different blood pressure levels]. C R Acad Hebd Seances Acad Sci D. 1975 Apr 7;280(13):1637-40. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure control	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.	One year
Primary	Glycemic control	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.	One year
Primary	Change of out-of-hospital visits	Change of extra-hospital visits during the monitoring period	One year
Secondary	Patient engagement in treatment	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.	One year
Secondary	Improvement in lifestyle	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).	One year

External Links

•   PubMed Single Citation Matcher