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临床试验/NCT03648957
NCT03648957已完成不适用

Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年10月1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
发起方
入组人数
40
试验地点
1
主要终点
Systolic blood pressure

研究概览

简要总结

Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in patients with acute minor stroke or transient ischemic attack who are discharged home.

详细描述

Stroke is a significant cause of morbidity, mortality, and loss of independence worldwide. In Denmark 12,000 people have a stroke per year. About one fourth of patients admitted with a stroke have had previous strokes or transient ischemic attack (TIA). The risk of recurrent stroke is highest in the first weeks and decreasing with time.

In the last decades there has been an increased focus on the importance of health behaviour in the public and among patients in relations to prevention of vascular diseases. There is solid scientific evidence of the harmful effects of lifestyle factors, such as smoking, physical inactivity, and alcohol overuse.

Hypertension is one of the leading risk factors for vascular diseases, including stroke and TIA. Lowering of the blood pressure is therefore an essential part of stroke treatment. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication is highly recommended in patients with minor stroke and TIA.

There is still a lack of knowledge about how to support patients in making suitable choices to prevent recurrence and progression of their disease. Previous research has shown varying results and it is therefore difficult to point out any specific intervention or element of interventions which would be feasible to implement in clinical practice.

The hypothesis of the study is that early client-centred patient counselling with repeated follow-up sessions after discharge can reduce the blood pressure through smoking cessation, physical activity, and improved adherence to preventive medication in patients with minor stroke and transient ischemic attacks compared to simple encouragement to lifestyle change.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female, age ≥ 18 years old
  • •Hospitalized patients with TIA (ICD-10 G45.9) or stroke (ICD-10 I61, I63, I64) with a Scandinavian Stroke Scale of 45-
  • •Diagnosis must by confirmed by a neurologist
  • •Discharge to their own home
  • •Able to give a valid written consent

排除标准

  • •Severe barriers to communication
  • •Not able to use a telephone
  • •Severe disability prior to the stroke (WHO Performance Status >2; mobilised less than 50 % of the day)
  • •Requiring specialized rehabilitation
  • •Active abuse of alcohol or narcotics
  • •Severe psychiatric illness (affective disease, dementia, schizophrenia, anxiety)

研究组 & 干预措施

Behavioral intervention

Experimental

Usual stroke service care plus additional lifestyle counselling focusing on smoking cessation, physical activity, and adherence to preventive medication. Regular follow-up sessions (3-4 weeks intervals). Physical activity is monitors by an activity tracker.

干预措施: Lifestyle counselling (Behavioral)

Behavioral intervention

Experimental

Usual stroke service care plus additional lifestyle counselling focusing on smoking cessation, physical activity, and adherence to preventive medication. Regular follow-up sessions (3-4 weeks intervals). Physical activity is monitors by an activity tracker.

干预措施: Activity tracker (Device)

Usual care

Active Comparator

Usual stroke service care; including computed tomography brain scan, neurological evaluation, and relevant cardiological/vascular evaluation (48-72 hour telemetry, echocardiography, carotic ultrasound imaging). At discharge all patients will receive written and verbal encouragement to a healthy lifestyle.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Systolic blood pressure

时间窗: At baseline (0 weeks) and end of intervention (12 weeks)

Change in resting systolic blood pressure from baseline to three months follow-up

次要结局

  • Recruitment rate(12 weeks)
  • Adherence rate(From baseline (0 weeks) until the end of intervention (12 weeks))

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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