The Effect of Nurse-Led Individual and Family-Involved Motivational Interviewing on Blood Pressure Control in Patients With Hypertension: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
Hypertension is one of the most important risk factors for cardiovascular morbidity and mortality. Effective hypertension management requires medication adherence, lifestyle modification, regular blood pressure monitoring, and self-management behaviors. Motivational interviewing is a counseling approach that may support behavior change and improve hypertension management.
This study aims to evaluate the effects of nurse-led individual motivational interviewing and family-involved motivational interviewing on blood pressure control in patients with hypertension. The study will be conducted as a single-center, three-arm, parallel-group, randomized controlled trial. A total of 180 patients with hypertension will be randomly assigned to one of three groups: usual care, individual motivational interviewing, or family-involved motivational interviewing.
Participants in the intervention groups will receive a 6-week nurse-led motivational interviewing program. In the family-involved motivational interviewing group, a family member who supports hypertension management will also participate in the sessions. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is systolic blood pressure. Secondary outcomes include diastolic blood pressure, hypertension knowledge level, treatment adherence, and hypertension self-efficacy.
详细描述
The study intervention is a non-invasive, education- and counseling-based behavioral nursing intervention. Participants in the control group will continue to receive routine hypertension care and will be given a standard hypertension information brochure. Participants in the individual motivational interviewing group will receive nurse-led individual motivational interviewing sessions. Participants in the family-involved motivational interviewing group will receive the same intervention, with the participation of a family member who supports the patient's hypertension management.
The intervention content includes hypertension awareness, individual risk factors, readiness for change, hypertension knowledge, misconceptions and complications, medication adherence, treatment barriers, salt reduction, nutrition behaviors, home blood pressure monitoring, physical activity, weight control, stress management, self-efficacy, problem solving, motivation maintenance, and individualized goal evaluation. Intervention fidelity will be monitored using a session checklist.
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 (Outcomes Assessor)
盲法说明
Participants and intervention providers cannot be masked due to the nature of the behavioral intervention. Outcome assessment and data analysis will be conducted with group codes masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Diagnosed with hypertension for at least 6 months
- •Using antihypertensive medication
- •Able to read and understand Turkish
- •Conscious and able to communicate
- •Providing written informed consent
- •Having at least one family member who can support hypertension management and participate in sessions when needed
排除标准
- •Advanced cognitive impairment
- •Active psychiatric crisis
- •History of a serious cardiovascular event within the last 3 months
- •Terminal illness
- •Serious physical condition that may prevent regular participation in intervention sessions
- •Concurrent participation in another structured education program
研究组 & 干预措施
Usual Hypertension Care With Information Brochure
Participants in this arm will continue to receive routine hypertension care. They will also receive a standard hypertension information brochure. No structured motivational interviewing intervention will be provided.
干预措施: Usual Hypertension Care With Information Brochure (Behavioral)
Nurse-Led Individual Motivational Interviewing
Participants in this arm will receive a 6-week nurse-led individual motivational interviewing program in addition to routine hypertension care. The intervention will focus on hypertension awareness, medication adherence, lifestyle modification, home blood pressure monitoring, physical activity, stress management, self-efficacy, problem solving, and maintenance of motivation.
干预措施: Individual Motivational Interviewing (Behavioral)
Nurse-Led Family-Involved Motivational Interviewing
Participants in this arm will receive the same 6-week nurse-led motivational interviewing program in addition to routine hypertension care, with the participation of a family member who supports hypertension management. The family member may support medication adherence, salt reduction, nutrition behaviors, home blood pressure monitoring, and weekly goals.
干预措施: Family-Involved Motivational Interviewing (Behavioral)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline, 6 weeks, and 18 weeks
Systolic blood pressure will be measured in mmHg using a standard blood pressure measurement procedure. Measurements will be taken after at least 5 minutes of rest using an appropriate cuff. At each assessment, at least two measurements will be taken from the same arm, and the average value will be used in the analysis. Lower systolic blood pressure values indicate better blood pressure control.
次要结局
- Diastolic Blood Pressure(Baseline, 6 weeks, and 18 weeks)
- Hypertension Knowledge Level Assessed by the Hypertension Knowledge-Level Scale(Baseline, 6 weeks, and 18 weeks)
- Treatment Adherence Assessed by the Hill-Bone Hypertension Treatment Adherence Scale(Baseline, 6 weeks, and 18 weeks)
- Hypertension Self-Efficacy Assessed by the Hypertension Self-Efficacy Scale(Baseline, 6 weeks, and 18 weeks)