试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change from Baseline in Systolic and Diastolic Blood Pressure at Month 3
研究概览
简要总结
Hypertension (HT) is defined as an arterial blood pressure persistently exceeding 140/90 mmHg in repeated measurements. It is a systemic disease characterized by chronically elevated blood pressure, which can lead to severe health complications. Despite advancements in screening, diagnosis, and treatment methods, hypertension remains a leading risk factor for mortality and disability in both developed and developing countries. Globally, approximately 1.3 billion individuals are living with hypertension. It is projected that within the next two decades, hypertension will become the most significant modifiable risk factor for non-communicable diseases. International guidelines recommend ambulatory blood pressure monitoring (ABPM) and/or home blood pressure monitoring (HBPM) for the diagnosis of hypertension. It has been demonstrated that home and/or ambulatory blood pressure measurements provide superior prognostic information regarding target organ damage and cardiovascular risk compared to clinic-based measurements. Nevertheless, both ambulatory and home blood pressure monitoring have several well-known limitations, including patient comfort, sleep disturbance, accessibility, and cost.
The use of various mobile technologies has been evaluated in different settings to improve hypertension management in primary care services. Mobile monitoring can lead to significant reductions in blood pressure (BP), decrease all-cause and hypertension-related hospitalizations, lower all-cause mortality and costs, and enhance quality of life. Furthermore, technology-assisted BP self-monitoring interventions have demonstrated superior BP control outcomes when combined with nurse-led mobile support, physician intervention, and medication review. This research, grounded in the integration of digital health technologies into nursing care, aims to enhance treatment adherence and the success of lifestyle modifications in hypertensive patients through mobile application-supported monitoring. Through this approach, the patient-nurse interaction will be strengthened, and self-management skills will be supported via personalized feedback.
详细描述
- Research Design/Model/Type:
Method of the study: This study is planned as randomized, controlled and experimental. Study Population and Sample The study population will consist of hypertensive patients who are under follow-up at the cardiology and internal medicine outpatient clinics of Kilis Prof. Dr. Alaeddin Yavaşca State Hospital. The sample will be composed of patients diagnosed with Hypertension (HT) who meet the inclusion criteria, with the sample size determined through a power analysis. Participants will be assigned to either an intervention or a control group using a simple random sampling method.
Intervention and Control Groups Participants in the intervention group will be provided with a digital blood pressure monitoring device with Bluetooth capability and a mobile application that integrates with this device. Measurements taken by the participants will be automatically recorded via the mobile application. Furthermore, the application will provide automated reminders for medication intake, scheduled blood pressure measurements, and follow-up appointments.
Participants in the control group will be given a standard digital blood pressure device without Bluetooth functionality, and their measurements will be stored in the device's internal memory. The control group will not receive any additional technological support, such as a mobile application or digital reminders.
Study Setting and Duration The study will be conducted at the cardiology and internal medicine outpatient clinics of Kilis Prof. Dr. Alaeddin Yavaşca State Hospital. The data collection process will commence after receiving the necessary approvals from the ethics committee and the institution. The total planned duration of the study is 18 months, which includes the phases of preliminary preparation, data collection, a three-month follow-up period, and analysis. 2. Study Group/Sample of the Study: The sample of this study will consist of a total of 40 patients, including 20 in the intervention group and 20 in the control group, as calculated based on a power analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hypertension at least 6 months prior.
- •Willingness to voluntarily participate in the study.
- •Aged 18 years or older.
- •Ability to use a smartphone.
- •Ability to read and write (literate).
排除标准
- •Patients with other serious cardiovascular diseases (e.g., heart failure, cardiac arrhythmia).
- •Inability to use a smartphone (for the intervention group).
- •Pregnancy.
- •Withdrawal of consent or request to leave the study.
- •Presence of any diagnosed psychiatric disorder.
结局指标
主要结局
Change from Baseline in Systolic and Diastolic Blood Pressure at Month 3
时间窗: Baseline, Month 3 (3 months)
Participants' blood pressure will be measured twice daily (morning and evening) for 3 months. In the intervention group, measurements are automatically transferred to a mobile application via Bluetooth-enabled devices. In the control group, measurements are recorded in the memory of standard digital devices. Results are reported in millimeters of mercury (mmHg). The change in mean blood pressure values between baseline and the end of Month 3 will be analyzed.
Change from Baseline in "Scale for Assessment of Treatment Adherence and Lifestyle Change Success in Hypertensive Individuals" Total Score at Month 3
时间窗: Baseline and Month 3
Treatment adherence and lifestyle changes will be assessed using the "Scale for Assessment of Treatment Adherence and Lifestyle Change Success in Hypertensive Individuals" (Hipertansif Bireylerin Tedaviye Uyum ve Yaşam Değişikliği Başarısını Değerlendirme Ölçeği) developed by Esirgen (2018). The scale consists of 18 items across 5 sub-dimensions (medical treatment adherence, communication with physician, healthy nutrition, physical activity and weight control, and salt and fast food consumption). The total score ranges from 18 (minimum) to 90 (maximum). Higher scores indicate better treatment adherence and positive lifestyle behaviors; a score of 68 or higher is considered "compliant". The change in the total score between baseline and the end of Month 3 will be analyzed.
次要结局
未报告次要终点
研究者
Mehmet Ali Bozkurt
PhD Student
University of Gaziantep