Implementation of a Nurse-Led Educational Intervention on Adverse Effects of Antihypertensive Drugs in Patients With Resistant Hypertension: Focus on Sexual Dysfunction, Urinary Incontinence, and Qualitative Insights.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
研究概览
简要总结
This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Diagnosis of resistant hypertension, defined as blood pressure not controlled despite the use of three or more antihypertensive medications.
- •Uncontrolled blood pressure as measured by ambulatory blood pressure monitoring (ABPM).
- •Resistant hypertension not secondary to other medical conditions (i.e., primary or essential hypertension).
- •No use of antihypertensive medications other than the prescribed ones, and no intake of licorice (which can interfere with blood pressure).
排除标准
- •Secondary causes of hypertension (e.g., endocrine disorders like hyperaldosteronism, pheochromocytoma, etc.).
- •Severe cognitive impairment that would prevent the patient from understanding the intervention or providing informed consent.
- •Uncontrolled psychiatric conditions that would interfere with participation (e.g., severe depression or psychosis).
- •Hospitalization during the study period.
- •Change of treatment regimen antihypertensive by a physician outside the study team (e.g., switching antihypertensive drugs or adding new medications without prior consultation with the study team).
- •Participation in another clinical trial that might interfere with the study outcomes.
- •Any other condition deemed inappropriate for study participation by the investigator.
研究组 & 干预措施
Educational intervention on the adverse effects of antihypertensive medication
Patients in this group will receive a nurse-led educational program focused on the adverse effects of antihypertensive medications, particularly sexual dysfunction and urinary incontinence. The intervention aims to provide patients with tools and strategies to manage these side effects, improve their understanding of antihypertensive drugs, and enhance their adherence to prescribed treatments. The intervention will include:
- One-on-one sessions with trained nurse.
- Education about common side effects of antihypertensives.
- Techniques to reduce the impact of side effects.
- Discussions around maintaining adherence to therapy.
- Strategies for addressing issues related to sexual health and urinary continence.
干预措施: Educational Intervention for Adverse Drug Effects (Behavioral)
Standard Care
Patients in this group will receive standard care as prescribed by their nurse, without the added educational component focused on the adverse effects of antihypertensives. This group will continue their usual treatment regimen for resistant hypertension, which may include medication adjustments and general counselling by nurse as part of their routine visits.
干预措施: routine care (Other)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
时间窗: Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.
The primary outcome of this study is the change in systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) before (baseline) and after the educational intervention (post-intervention). A reduction of at least 10 mmHg in systolic blood pressure is considered a significant clinical improvement. This outcome will be measured during both routine clinical visits and study-specific visits to assess the effectiveness of the nurse-led educational intervention in improving blood pressure control.
次要结局
- Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention(Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program)
- Medication Adherence Rate(Adherence will be measured at baseline and post-intervention (at 6 months).)
- sexual dysfunction(At baseline and 6 months after the intervention.)
- urinary incontinence(At baseline and 6 months after the intervention.)