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

NCT05843682 | Unknown DMC

• 1 other identifier: 5483/22/06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension; Metabolic Cardiovascular Syndrome; Heart Disease Risk Factors

Keywords

Remote telemonitoring; Uncontrolled hypertension; Artificial intelligent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Patient engagement in treatment

  One year

• Improvement in lifestyle

  One year

Study Arms (2)

Avatr

OTHER

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

Control

NO INTERVENTION

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.

Interventions

Using the Avatr App 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.

Avatr

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stroke sequelae
• Cognitive dysfunction

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator

Study Sites (1)

Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

São Paulo, Brazil

Location

Related 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.

  PMID: 152 RESULT

Related Links

• PubMed Single Citation Matcher

MeSH Terms

Conditions

Essential Hypertension; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fábio B Jatene, MD, PHD

  Heart Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: May 6, 2023
• Study Start: October 7, 2022
• Primary Completion: August 31, 2023
• Study Completion: February 29, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)