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NCT05575232Completed

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

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

Source: ClinicalTrials.gov · Last updated 9 May 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
52 (actual)
First submitted
13 Sept 2022
Start date
1 Oct 2022
Primary completion date
1 Dec 2023
Lead sponsor
Universidade Federal de Santa Catarina
NCT number
NCT05575232

What you commit to

  • Study type: Interventional
  • Participants enrolled: 52
  • From 1 Oct 2022 to the primary completion date, 1 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universidade Federal de Santa Catarina
Coordinator of this site? Confirm its status
FlorianópolisBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.