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

Study Overview
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Brief Summary
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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).

Detailed Description
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The study will be developed in three stages, according to the objectives outlined. Initially, a prototype of a cellphone application will be developed to help Brazilian adults diagnosed with SAH, with tools related mainly to medication adherence, promotion of physical activity and monitoring of blood pressure values, in addition to health tips (food, smoking, alcoholism and stress management). Subsequently, this prototype will be made available to a group of adult hypertensive patients so that the effectiveness of this application can be tested on laboratory blood pressure values, medication adherence and lifestyle aspects, including physical activity and, subsequently, physical activity. Application usability will be tested. Subsequently, after making the necessary adjustments, the application will be made available on the Apple iTunes and Google Play platforms and disseminated in groups of Basic Health Units and in the media (advertisements on television, newspaper, radio). From there, the number of downloads and the grade assigned to user reviews (one, two, three or four stars) will be evaluated, according to the user's sociodemographic characteristics (gender, age, place of residence). App Development General Description 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 theme. After downloading, patients must manually enter demographic data (date of birth, sex), their body mass and height, information regarding the use of the drugs used, the presence of comorbidities (diabetes, dyslipidemia, chronic kidney disease, coronary artery disease, peripheral arterial disease, among others). In addition, the user must enter data related to their lifestyle, including information about: physical activity, nutrition, alcohol consumption, tobacco use, stress and relationships, according to an adapted version of the Fantastic lifestyle. Based on this information entered by the patient (input), the application will issue reminders: a) for the use of the medication(s), according to the time registered by the patient, daily; b) to perform blood pressure measurements. The patient will be instructed to take blood pressure measurements while sitting, in a calm environment, after five minutes of rest, with the bladder emptied and there is at least 30 minutes of abstention from food, cigarettes and/or alcoholic and caffeinated beverages. Such measured BP values must be entered in the application and, if a BP level above the recommended values is identified, the insertion of the importance of the correct use of antihypertensive medication and adoption of a healthy lifestyle will increase. It will also be suggested that you consult your doctor for possible medication adjustments. In addition, the user will be given the possibility to self-monitor their physical activities and, based on this information, the application will generate feedback informing whether or not the user has reached the recommendations currently in force. If the user does not meet the recommendations throughout the week, illustrative messages or videos will be generated with stimuli and guidelines for the patient to increase their level of physical activity, according to such recommendations. Illustrative messages or educational videos will also be made available with tips on healthy living habits, including recommendations for body weight control, reducing sodium consumption, adopting healthy eating habits, stress control and smoking cessation, as recommended by the main guidelines related to thematic. Reports for the patient regarding blood pressure values and physical activity will be available, showing the evolution over time. For programmers and researchers, these same reports will also be generated, in addition to reports with application usage statistics and general user characteristics (business intelligence), so that, with this information, the system can be feedback. Patients will be able to designate family members and/or friends to have access to the data captured and generated by the application, so that these people can provide social support for the treatment of hypertensive patients. In addition, a communication channel will be opened between patients that the application identifies in closer locations, in case the patient wants to share doubts, challenges and achievements.

Official Title
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Effectiveness and Usability of a Mobile Application to Assist in the Pharmacological and Non-pharmacological Treatment of Arterial Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Application Group (GA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: Changes in the type and/or dose of antihypertensive drugs used during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application Group (GA)<br>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)<br>* 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.<br>|
| No Intervention: Control Group (GC)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in medication adherence levels | Will be assessed using the Morisky's Therapeutic Adherence Scale of eight items | up to 8 weeks | 
| Changes in physical activity leves | Will be assessed using accelerometry, using devices of the GT3X and GT3X+ models (Actigraph Pensacola, FL, USA) and the Actilife software (Actigraph Pensacola, FL, USA) | up to 8 weeks | 
| Changes in lifestyle | Will be evaluated using an adapted version of the Fantastic questionnaire which includes questions related to the following components: nutrition, physical activity, preventive behavior, social relationships and stress control. For each question, patients will answer whether such behavior is not part of their lifestyle, rarely matches, almost always matches, or always matches. | up to 8 weeks | 
| Patient satisfaction with the application | Patients undergoing the GA will be invited to answer an adapted version of the assessment scale for smartphone applications for health care, proposed by Jim and Kim 24, which contains 23 items in total, related to the assessment of content, objectivity, interface design, writing style and technology, with response options ranging from zero (not at all) to four (a lot), generating an overall score. | through study completion, an average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Mobile Health