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

Primary Purpose

Essential Hypertension, Metabolic Cardiovascular Syndrome, Heart Disease Risk Factors

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Using the Avatr App
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Essential Hypertension focused on measuring Remote telemonitoring, Uncontrolled hypertension, Artificial intelligent

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 Exclusion criteria: Stroke sequelae Cognitive dysfunction

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Avatr

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change of out-of-hospital visits
Change of extra-hospital visits during the monitoring period

Secondary Outcome Measures

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.
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).

Full Information

First Posted
December 1, 2022
Last Updated
April 24, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05843682
Brief Title
Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2
Acronym
Hyper2
Official Title
Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Metabolic Cardiovascular Syndrome, Heart Disease Risk Factors
Keywords
Remote telemonitoring, Uncontrolled hypertension, Artificial intelligent

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avatr
Arm Type
Other
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Using the Avatr App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure control
Description
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.
Time Frame
One year
Title
Glycemic control
Description
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.
Time Frame
One year
Title
Change of out-of-hospital visits
Description
Change of extra-hospital visits during the monitoring period
Time Frame
One year
Secondary Outcome Measure Information:
Title
Patient engagement in treatment
Description
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.
Time Frame
One year
Title
Improvement in lifestyle
Description
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).
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion criteria: Stroke sequelae Cognitive dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio B Jatene, MD, PHD
Organizational Affiliation
Heart Institute
Official's Role
Study Director
Facility Information:
Facility Name
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
152
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=Bortolotto%2C+LA%5BAuthor%5D
Description
PubMed Single Citation Matcher

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

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