Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 4
- 主要终点
- The main outcome of the study was the mean difference between groups in the average reduction in systolic and diastolic blood pressure between baseline and the end of follow-up
研究概览
简要总结
A number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (BP) control and adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults.
Participants will receive usual care and a guideline-based educational program on BP control and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for CVD prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmHg; or
- •diastolic blood pressure ≥ 90 mmHg).
- •speaking and reading Italian,
- •having a active phone number and an email address, and
- •providing a signed informed consent.
排除标准
- •mental illness;
- •nursing home institutionalization;
- •pregnancy;
- •previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).
结局指标
主要结局
The main outcome of the study was the mean difference between groups in the average reduction in systolic and diastolic blood pressure between baseline and the end of follow-up
时间窗: 6 months
次要结局
- Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up(6 months)
- Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up(6 months)
- Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up(6 months)
研究者
Lamberto Manzoli
Associate Professor of Epidemiology and Public Health
Università degli Studi 'G. d'Annunzio' Chieti e Pescara