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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fábio B Jatene, MD, PHD | Heart Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor), Hospital das Clinicas do HCFMUSP | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 152 | Result | 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. |
| Label | URL |
|---|---|
| PubMed Single Citation Matcher | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2023 | Apr 24, 2023 |
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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 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2023 | Apr 24, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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