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临床试验/NCT03442257
NCT03442257已完成不适用

PUSH ME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension: a Randomized Controlled Pilot Trial

Lund University6 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
6
主要终点
Change in blood pressure

研究概览

简要总结

The primary objective of the study is to examine the impact of lifestyle advices, administered through regularly sent SMS, on hypertension in a primary health care setting. The secondary objective is to evaluate changes in other cardiovascular risk factors and general health, e.g. tobacco use, obesity, blood lipids, blood glucose, self-rated health and health-related quality of life.

详细描述

Background- The globalization of unhealthy lifestyles and demographic ageing of the world's population has contributed to the fact that high blood pressure is classified by World Health Organization as the world's leading risk for mortality.

Persistent hypertension is a key risk factor for coronary heart disease (CHD), stroke and other cardiovascular diseases (CVD), such as heart failure. CVD is, despite a decline in recent decades, still the leading cause of death in Sweden (4). The prevalence of hypertension in adults is around 40% according to a recent multinational study (5). In 30-40% of hypertensive individuals, additional metabolic risk factors such as dyslipidemia, insulin resistance and elevated glucose occur simultaneously, which further multiply the risk for heart disease, diabetes and stroke. An unhealthy lifestyle with physical inactivity and excess energy intake is the major driver of these metabolic risk factors. In most cases lifestyle intervention can reverse or reduce the unfavorable metabolic profile.

Primary healthcare in Sweden is managing the first-line healthcare, offering both prevention and treatment for a majority of chronic diseases. In Sweden, the vast majority of patients with hypertension are treated in primary health care. If the hypertension is well controlled, the GP typically meets the patient once a year for medical checkup, blood tests and medical prescription.

Interventions by SMS-texting have been shown to significantly improve compliance to medications, follow-up rate or disease monitoring.

Trial Design - Randomised clinical trial

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The research assistant, the patients' GPs, as well as all researchers except one (MS) will be blinded to group allocation. If the patients have questions regarding the SMS function they will be able to contact MS for help.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9).
  • 40 to 80 years of age
  • Patient must own a mobile phone compatible with SMS

排除标准

  • History of myocardial infarction, stroke, transient ischemic attack (TIA), claudicatio intermittens, abdominal aortic aneurysm, previous heart surgery i.e. PCI or bypass (reported by recruiting physician or by patient in the questionnaire)
  • Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure <120 mmHg.
  • Serious illness, other than cardiovascular, with short life expectancy (<1 year)
  • Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.

研究组 & 干预措施

SMS group

Experimental

Participants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

干预措施: SMS (Behavioral)

Control

No Intervention

The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.

结局指标

主要结局

Change in blood pressure

时间窗: Six months

Measured by automated devices (mmHg)

次要结局

  • Changes in cholesterol(six months)
  • Changes in tobacco use(six months)
  • Changes in low-density lipoprotein [LDL](six months)
  • Changes in high-density lipoprotein [HDL](six months)
  • Changes in BMI(six months)
  • Changes in Blood glucose(six months)
  • Changes in level of physical activity(six months)
  • Changes in alcohol use(six months)
  • Changes in self-rated health(six months)
  • Changes in self rated quality of life(six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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