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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Essential Hypertension; Metabolic Cardiovascular Syndrome; Heart Disease Risk Factors
• Intervention / Treatment: Device: Using the Avatr App

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change of out-of-hospital visits	Change of extra-hospital visits during the monitoring period	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: InCor Heart Institute
• Investigators: Study Director: Fábio B Jatene, MD, PHD, Heart Institute

Publications and helpful links

General Publications

• 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.

Helpful Links

• PubMed Single Citation Matcher

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): February 29, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Uncontrolled hypertension; Remote telemonitoring; Artificial intelligent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Heart Diseases; Hypertension; Metabolic Syndrome; Essential Hypertension
• Other Study ID Numbers: 5483/22/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No