Check and Support -Pragmatic Randomized Controlled Study of the Effectiveness of 12 Month SMS-Text Message Support and IMB-based Initiation of Medication in Adults With Hypertension for Better Blood Pressure Control and Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 12
- 主要终点
- The proportion of patients achieving the systolic blood pressure target at 12-month follow-up
研究概览
简要总结
The purpose of this pragmatic multi-centre, cluster randomized controlled trial is to test the effectiveness of tailored SMS-text message support combined with an information-motivation-behavioral skills (IMB) model-based initiation of medication in helping outpatient care patients with hypertension to achieve blood pressure target and to enhance medication adherence.
详细描述
Background
Usual blood pressure is strongly related to vascular and overall mortality and high blood pressure is globally the leading risk factor for cardiovascular and related diseases. It is also well established that pharmacologic blood pressure reduction prevents cardiovascular events and deaths in persons with hypertension.
Today's physicians have plenty of knowledge and multiple effective and safety tools to treat hypertension but still majority of patients with antihypertensive medication do not achieve the blood pressure target. Poor medication adherence has been widely accepted to be the most important factor in failing to control hypertension and even 50% of hypertensive patients quit the antihypertensive medication during the first year of medication.
Numerous interventions to enhance medication adherence have been developed but even though, an intervention effective, simple and low cost enough to be carried out wide-scale in non-research settings is still to be found.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of hypertension
- •About to start medication for hypertension for the first time
- •Aged 30-75 years
- •Must own a mobile phone
- •Must be able to read text messages
- •Must be able to master own medication
- •Must be able to perform home BP measurements
- •Must agree in using electric drug prescription (standard in Finnish health care)
排除标准
- •Having or is suspected to have depression or psychosis
- •Serious disease, which is evaluated to have an impact on life expectancy
- •Atrial flutter or atrial fibrillation
- •Previous history of antihypertensive medication
- •Pregnancy
- •Not willing to give informed consent and take part in the study
- •Systolic BP more than 200 mmHg
- •Diastolic BP more than 120 mmHg
- •Sudden onset or worsening of hypertension
- •Clinical signs of kidney disease: proteinuria (du-prot > 500 mg), glomerulus filtration rate (eGFR) less than 45 ml/min or hypokalemia
研究组 & 干预措施
Usual care (Reference group)
Treatment is leaded by treating physician according to national guide lines with no study-specific medication or clinical appointment protocol.
干预措施: Usual care (Behavioral)
An IMB model-based initiation of medication
In addition to usual care, participants allocated to intervention group will receive
An IMB model-based initiation of medication i.e. a nine-point check list to be fulfilled by physician and patient together when ordering the antihypertensive medication for the first time
干预措施: IMB model-based initiation of antihypertensive medication (Behavioral)
An IMB model-based initiation of medication
In addition to usual care, participants allocated to intervention group will receive
An IMB model-based initiation of medication i.e. a nine-point check list to be fulfilled by physician and patient together when ordering the antihypertensive medication for the first time
干预措施: Tailored SMS-text message support (Behavioral)
Tailored SMS-text message support
Tailored SMS-text message support for the first 12 months of medication. At the beginning (2 weeks), text messages are send on daily basis and focused on medications-reminders and coping with potential side-effects of medication.
After that, text messages will be sent less often and the focus will change to keeping up with medication and reminding of importance of performing adequate home BP self-monitoring, achieving the BP target and attending clinical appointments.
干预措施: Tailored SMS-text message support (Behavioral)
Tailored SMS-text message support
Tailored SMS-text message support for the first 12 months of medication. At the beginning (2 weeks), text messages are send on daily basis and focused on medications-reminders and coping with potential side-effects of medication.
After that, text messages will be sent less often and the focus will change to keeping up with medication and reminding of importance of performing adequate home BP self-monitoring, achieving the BP target and attending clinical appointments.
干预措施: IMB model-based initiation of antihypertensive medication (Behavioral)
结局指标
主要结局
The proportion of patients achieving the systolic blood pressure target at 12-month follow-up
时间窗: 12 months from baseline
The proportion of patients (%) achieving systolic office blood pressure (BP) target (\<140 mmHg) and home BP target (\<135 mmHg) are both analyzed separately using mixed effects model. Both office BP and home BP are measured with a validated blood pressure monitoring device (Microlife Watch BP Home A or Microlife Watch BP Home N) after appropriate rest from the left arm with an appropriately sized semi-rigid conical cuff. Office BP is the mean of three measurements separated by 15 seconds. Home BP is measured correspondingly three times in the morning and in the evening on 7 consecutive days at 12 months. Home BP is the mean of all available measurements.
次要结局
- Hypertension-related use of health care services(0-12 months from baseline)
- The proportion of participants knowing the adequate home BP target(baseline and 12 months from baseline)
- Blood glucose level(baseline and 12 months from baseline)
- Measured medication adherence(12 months from baseline)
- Change in systolic and diastolic blood pressure(12 months from baseline)
- Blood cholesterol level(baseline and 12 months from baseline)
- Microalbuminuria(baseline and 12 months from baseline)
- Creatinine level(baseline and 12 months from baseline)
- Alcohol use(baseline and 12 months from baseline)
- Perceived quality of life(baseline and 12 months from baseline)
- The proportion of patients whose BP target is adequately set(12 months from baseline)
- The quality and quantity of self-monitored blood pressure(baseline and 12 months from baseline)
- ECG(baseline and 12 months from baseline)
- Body mass index(baseline and 12 months from baseline)
- Waist circumference(baseline and 12 months from baseline)
- Exercising habits(baseline and 12 months from baseline)
- Smoking(baseline and 12 months from baseline)