Effectiveness and Usability of a Mobile Application to Assist in the Treatment of Arterial Hypertension

NCT05575232 | Completed DMC

• 1 other identifier: APP PRESSÃO NA BOA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic arterial hypertension (SAH) is a multifactorial cardiovascular disease that stands out as an important risk factor for the development of other cardiovascular diseases, such as ischemic heart disease and stroke, which are the main causes of death in Brazil and in the world. In this sense, SAH is considered a major public health problem, given its high prevalence. However, despite the evidence of several effective treatments for SAH, in Brazil, it is estimated that 77% of hypertensive patients do not undergo any treatment. Among the possible reasons for this, the low adherence to the proposed treatment (pharmacological and non-pharmacological) and the deficiencies in health care systems in approaching the treatment of chronic diseases, such as SAH. In this context, in order to improve the control and treatment of patients with SAH, the development of innovative methodologies that provide strategies to increase adherence to drug treatment and facilitate changes in lifestyle are necessary. In this sense, the present proposal aims to develop an application for smartphones aimed at the treatment of SAH, with tools aimed at medication adherence, blood pressure monitoring, monitoring and promotion of physical activity and healthy lifestyle habits in hypertensive patients. Therefore, the study will be developed in three phases: Phase 1: application development; Phase 2: testing the effectiveness of the application in a controlled environment; and, Phase 3: usability testing of the application. In phase 2, a randomized controlled clinical trial will be conducted to test the effect of eight weeks of application use on laboratory blood pressure, physical activity level, adherence to medication treatment and general lifestyle. In Phase 3, the app will be available on Apple iTunes and Google Play. After the application is publicized in the media (advertisements on television, newspapers, radio) and in social groups, usability aspects will be evaluated, such as the number of downloads and the grade attributed to user evaluations, according to the sociodemographic characteristics of the user (sex, age, place of residence).

Conditions

Hypertension

Keywords

Hypertension; Mobile Health

Outcome Measures

Primary Outcomes (2)

• Changes in clinic systolic blood pressure

  The laboratory blood pressure (systolic and diastolic) will be obtained in two days, at a similar time, using the OMRON automatic equipment, model 742HEM. On each day, three measurements will be performed with an interval of one minute between them, with the cuff placed on the left arm, elevated to the height of the midpoint of the sternum. If the variation of these three measurements is greater than 4 mmHg for systolic and/or diastolic blood pressure, new measurements will be performed until this established criterion is met. The average value between the measurements obtained on the different days will be recorded as a reference value at the different moments of the study.

  up to 8 weeks

• Changes in clinic diastolic blood pressure

  The laboratory blood pressure (systolic and diastolic) will be obtained in two days, at a similar time, using the OMRON automatic equipment, model 742HEM. On each day, three measurements will be performed with an interval of one minute between them, with the cuff placed on the left arm, elevated to the height of the midpoint of the sternum. If the variation of these three measurements is greater than 4 mmHg for systolic and/or diastolic blood pressure, new measurements will be performed until this established criterion is met. The average value between the measurements obtained on the different days will be recorded as a reference value at the different moments of the study.

  up to 8 weeks

Secondary Outcomes (4)

• Changes in medication adherence levels

  up to 8 weeks

• Changes in physical activity leves

  up to 8 weeks

• Changes in lifestyle

  up to 8 weeks

• Patient satisfaction with the application

  through study completion, an average of 8 weeks

Study Arms (2)

Application Group (GA)

EXPERIMENTAL

Participants undergoing the GA will be instructed on how to download the application and how to use it. From there, all personal data must be entered into the application so that alerts, tips and incentives can be issued to each one, individually.

Behavioral: Application Group (GA)

Control Group (GC)

NO INTERVENTION

The GC, in turn, will participate in a single lecture, in the first week of the intervention, with basic guidelines related to the key points of the treatment of SAH, including the importance of medication adherence, monitoring of blood pressure values and/or capillary glucose, lifestyle modifications linked to physical activity, eating habits, smoking cessation, stress management and moderate alcohol consumption.

Interventions

Application Group (GA) BEHAVIORAL

The main focus of the application is to assist in the treatment of patients with SAH. The application will address the components of adherence to medication use, blood pressure monitoring and promotion/monitoring of physical activity. In addition, health education tips will be provided, including guidelines for reducing sodium consumption, adopting an adequate and healthy diet, controlling body weight, moderate alcohol consumption and stress management, in accordance with the recommendations of the main guidelines related to the theme¹ ³. The intervention will last eight weeks.

Application Group (GA)

Eligibility Criteria

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

You may qualify if:

• Have a clinical diagnosis of SAH;
• Have been using antihypertensive medication for more than three months;
• Cannot be involved in the regular practice of physical activities.
• Have a smartphone.
• Not have cognitive disabilities that limit the understanding and use of an application and/or physical limitations that make it difficult to practice physical activities;

You may not qualify if:

• Changes in the type and/or dose of antihypertensive drugs used during the study.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

Related Publications (23)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ALINE M GERAGE, PHD

  UNIVERSIDADE FEDERAL DE SANTA CATARINA (UFSC)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 12, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)