Role of Self Monitoring in Combination With Proactive Web-based Management in the Treatment of Hypertension: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Systolic bloodpressure
研究概览
简要总结
The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of self-measuring of the blood pressure at home and the use of a pro-active web-based feedback system on the blood pressure, number of antihypertensive drugs used, and surrogate cardiovascular markers during a 12 month period will be investigated.
详细描述
Patients are assigned to the intervention or control group (1:1 ratio) by the research nurse based on a computer-generated allocation sequence. Stratified randomization will be performed to allocate equal numbers of patients with and without diabetes in both groups. This is an open trial without masking of the participants or investigators. Outcome measures are not blinded.
Patients meeting the inclusion criteria will be asked to participate in the study. After informed consent is given, all patients will be seen by the nurse practitioner and the doctor (coordinator of the study) for an intake. During this intake patients will be informed about the study, medical history will be taken, questionnaires are completed a physical examination is performed and BP measurements and laboratory tests are performed. The patients will also receive information about hypertension and personal lifestyle advises during the intake. After inclusion, patients are randomized into two groups:
- Control group: After the intake the patients will receive usual care at the outpatient clinic. After one year the coordinator of the study and the nurse practitioner will see the control group patients for a final evaluation. During this evaluation, the questionnaires, measurements and laboratory tests are repeated.
- Intervention group: After the intake, patients receive a HBP-monitor and a login account to a personal website. Furthermore, instructions about the use of the home blood pressure monitor and the website will be given. The web-based program can be used by the patient to upload the blood pressure readings and to communicate with the nurse practitioner or to the doctor and vice versa. Patients can ask questions daily and will receive personal lifestyle advices on monthly basis. If needed, medication adjustments will be made based on the blood pressure measurements. Online information will be provided to the patients as a reference work with information about hypertension, treatment strategies and technical facts of the blood pressure monitor and the website. Patients in the intervention group will visit their own physician in the OPD after 6 months, instead of every 3 months. If necessary patients can visit their physician earlier. If patients have multiple diseases, regular visits to the internal medicine department are not restricted.
After 12 months, patients in the intervention and control groups are seen for the final evaluation.
Data registered only during intake:
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
- None
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
- 否
入选标准
- •Age between 18 and 80 years.
- •Use of 3 or more antihypertensive medications.
- •Use of 0,1 or 2 antihypertensive medications and a documented BP equal or greater than 140/90 mmHg (non-diabetic patients)
- •Use of 0,1 or 2 antihypertensive medications and a documented BP equal or greater than 130/80 mmHg (diabetic patients)
- •Patients must be able to measure the BP at home and to communicate with the nurse or physician through the web-based system.
排除标准
- •Younger than 18 years of age, older than 80 years of age.
- •Not fluent in Dutch or English language
- •Pregnancy
- •Life expectancy less than one year
- •No access to a computer or internet
- •Most recent creatinine clearance (24 hour creatinine clearance) < 30 ml/min
- •Class III or IV heart failure
结局指标
主要结局
Systolic bloodpressure
时间窗: 12 months
Diastolic bloodpressure
时间窗: 12 months
次要结局
- lifestyle changes(12 months)
研究者
Prabath W.B. Nanayakkara
MD, PhD, FRCP
Amsterdam UMC, location VUmc