National Defense Medical Center
试验速览
- 阶段
- 不适用
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- evaluate the effects of self-titration strategy on the improvement of home blood pressure
研究概览
简要总结
This study aims to investigate the relationship among self-efficacy, anxiety, depressive symptoms, quality of life, lifestyle, heart rate variability and blood pressure control; and to examine the effects of self-titration strategy on self-efficacy, anxiety, depressive symptoms,heart rate variability, sodium excretion, lifestyle modification,quality of life, and blood pressure control in patients with hypertension.
详细描述
Background: Hypertension is the major cause of mortality for the cardiac, vascular and renal disease. The effective control of elevated blood pressure may reduce the damages of several target organs. World Health Organization points out "Innovation and Empowerment for health". The self-titration strategy may empower patients to self-control their diseases, share decision-making and increase their ability to self-management their situations and improve their home blood pressure.
Methods: This experimental study included 222 hypertensive patients from outpatient services of cardiology departments of a medical center in northern Taiwan. We randomly divided the 72 patients into the experimental group (n=111) and control group (n=111). The experimental group received self-titration strategy training and lifestyle modification education; the control group received usual care and lifestyle modification education.
Data were collected for self-efficacy, anxiety symptoms, depressive symptoms, lifestyle and health-related quality of life using self-report questionnaires. Heart rate variability was measured with CheckMyHeart device (DailyCare BioMedical, Chungli, Taiwan). Patients evaluated their home blood pressure by corrected sphygmomanometer. We used the generalized estimating equation to evaluate the effects of the intervention.
Purpose: Primary outcome to evaluate the effects of self-titration strategy on the improvement of home blood pressure in patients with hypertension. Secondary outcomes to evaluate the effects of self-titration strategy on the improvement of self-efficacy, anxiety, depressive symptoms and lifestyle quality of life in patients with hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 years old.
- •diagnosed with primary hypertension.
- •no addiction to drugs or alcohol.
- •not using anti-depression therapy.
- •able to read and understand Chinese or Taiwanese.
- •willing to participate in this study.
排除标准
- •arrhythmia.
- •major psychiatric disorders
- •thyroid disease.
- •had received a heart transplant, a permanent pacemaker or an implantable cardioverter defibrillator, diagnosed with (6) cancer, (7) heart failure, or (8) acute myocardial infarction.
研究组 & 干预措施
Intervention Group
The intervention group receives self-titration strategy training and lifestyle education.
干预措施: Self-titration strategy (Behavioral)
Control Group
The control group receives usual care and lifestyle education.
结局指标
主要结局
evaluate the effects of self-titration strategy on the improvement of home blood pressure
时间窗: up to 3 months
Patients evaluated their home blood pressure by corrected sphygmomanometer.
次要结局
未报告次要终点
研究者
Fung-Wei Chang
Director, Head of Obstetrics and Gynecology
Tri-Service General Hospital