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Набор скоро начнётся NCT07556419

Development of a Mobile Application Called TansiyoRitim for Hypertension Patients

Без фазы С лечением Hypertension Mobile Application Blood Pressure Control Treatment Adherence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mobile application, control group.
Кому может быть актуально
Состояния в реестре: Hypertension, Mobile Application, Blood Pressure Control, Treatment Adherence. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of a Mobile Application Developed for Hypertension Patients on Blood Pressure Control, Treatment Adherence, and Self-Efficacy: A Randomized Controlled Trial

Обзор

Based on King's Theory of Goal Success, this project is designed to develop a mobile application called TansiyoRitim for individuals over the age of 18 diagnosed with hypertension. The research consists of the following phases: creating educational content, designing the mobile application, and evaluating the application and its effectiveness. Within the scope of the research, participants' blood pressure control, self-efficacy levels, and treatment adherence behaviors will be assessed using valid and reliable measurement tools, and the goal is to support these behaviors through the developed mobile health application. Participants' clinical treatment processes, pharmacological treatment adjustments planned by the physician, and changes in medication dosages will be excluded from the scope of the project. No intervention will be made in the medical treatment currently being administered during the study; participants' routine clinical follow-up and treatment processes will continue within the framework of standard care. Only educational and mobile app-based supportive interventions will be implemented within the scope of the research.

Подробное описание

Hypertension, a systemic disease characterized by persistently high blood pressure, is a significant health problem due to its widespread prevalence in the population and the serious complications that can develop if left uncontrolled. In the treatment of hypertension, maintaining blood pressure control is crucial for treatment success. In addition to pharmacological methods, lifestyle modifications such as weight management, smoking cessation, regular exercise, sleep hygiene, salt restriction, balanced nutrition, and stress reduction are also commonly used. The literature reports that interventions aimed at improving the health behaviors of hypertensive patients, presented through methods that encourage active participation and are enriched with digital tools, are more effective than traditional methods in terms of learning outcomes and lasting behavioral change. This study aims to evaluate the effect of a mobile health application structured on King's Goal Achievement Theory on blood pressure control, treatment adherence, and self-efficacy in hypertensive patients. The unique aspect of this research is that the mobile application developed for hypertensive patients offers a learning and care approach that supports mutually goal-oriented interaction between the individual and the system, rather than simply being an information-providing tool. This project, the first of its kind to be conducted under nurse leadership and unique to the culture of the province where the study is taking place, features a mobile application for blood pressure control. Another unique aspect is the development of a collaborative model that contributes to the multidisciplinary management of hypertension through an individualized care protocol structured based on King's Goal Achievement Theory, developed under nurse leadership. These achievements make our project unique and innovative for our country. The research will be conducted in a hospital in Kars using a randomized controlled experimental design including pre-test, post-test, and interim measurements. 160 participants, determined by power analysis, will be randomly assigned to the mobile application group (n=80) and the control group (n=80) via a computer-based randomization list created using the R program. Participants in the mobile app group will begin using the TansiyoRitim mobile app, which is available for download on Google Play and the App Store. The app is structured according to the theoretical components of King's Theory of Targeted Success and is designed to promote behavior change in patients with hypertension. The study outcomes will be evaluated using a Demographic Information Form, a Blood Pressure Monitoring Form, the Hill-Bone Hypertension Treatment Adherence Scale, the Hypertension Self-Efficacy Scale, and a Mobile Application Usability Scale. This project aims to generate scientific evidence regarding the effectiveness of a mobile health application developed for hypertension patients, support individuals' active participation in their health processes through the mobile application, contribute to the dissemination of digital health-based approaches in academic and applied fields, and share the results of this project in international literature.

Вмешательства

  • Поведенческое Mobile application
    The mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders.
  • Поведенческое control group
    The control group will not be interfered with.

Первичные конечные точки

  • Demographic Information Form [Срок оценки: At baseline]
  • Blood Pressure Measurement and Monitoring Form [Срок оценки: From baseline to Month 3]
  • Hill-Bone Hypertension Treatment Adherence Scale (HBHTTUÖ) [Срок оценки: Baseline and Month 3]
  • Hypertension Self-Efficacy Scale [Срок оценки: Baseline and Month 3]
Вторичные конечные точки (2)
  • Mobile Application Usability Scale [Срок оценки: The Mobile Application Usability Scale will be used for both expert and patient evaluations. Outcome 1 (Experts): At baseline Outcome 2 (Patients): At Month 3]
  • DISCERN (Quality Criteria for Consumer Health Information) [Срок оценки: At baseline]

Критерии участия

Критерии включения

  • Diagnosed with hypertension at least 1 year prior to enrollment
  • Currently using antihypertensive medication
  • Able to use a smartphone
  • Able to measure blood pressure at home
  • No severe visual or hearing impairment
  • Able to communicate in Turkish
  • Literate
  • Willing to participate and provide informed consent

Критерии исключения

  • Age under 18 or over 85 years
  • Presence of severe comorbid chronic disease affecting participation
  • Severe physical or cognitive impairment preventing participation
  • Body mass index (BMI) ≥ 30 kg/m²

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kafkas University — Kars

Идентификаторы

NCT: NCT07556419 · 80576354-050-99/886

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗