The NAILED stroke risk factor trial (Nurse based Age independent Intervention to Limit Evolution of Disease after stroke): study protocol for a randomized controlled trial

Trials

Joachim Ögren¹  Anna-Lotta Irewall⁴  Lisa Bergström³  Thomas Mooe² 

[1] Department of Internal Medicine, Section of Cerebrovascular Diseases, Östersund Hospital, Östersund, Sweden;Department of Internal Medicine, Section of Cardiology, Östersund Hospital, Östersund, Sweden;Department of Internal Medicine, Section of Neurology, Östersund Hospital, Östersund, Sweden;Department of Public Health and Clinical Medicine, Umeå University, Östersund, Sweden

关键词: Randomized controlled trial;    Cardiovascular diseases;    Secondary prevention;    Stroke;   

Others  :  1095002
DOI  :  10.1186/1745-6215-14-5

 received in 2012-07-31, accepted in 2012-12-18,  发布年份 2013

【 摘 要 】

Background

Secondary prevention after stroke and transient ischemic attack (TIA) is essential in order to reduce morbidity and mortality. Secondary stroke prevention studies have, however, been fairly small, or performed as clinical trials with non-representative patient selection. Long-term follow-up data is also limited. A nurse-led follow-up for risk factor improvement may be effective but the evidence is limited. The aims of this study are to perform an adequately sized, nurse-led, long-term secondary preventive follow-up with a population-based inclusion of stroke and TIA patients. The focus will be on blood pressure and lipid control as well as tobacco use and physical activity.

Methods

A randomized, controlled, long-term, population-based trial with two parallel groups. The patients will be included during the initial hospital stay. Important outcome variables are sitting systolic and diastolic blood pressure, LDL cholesterol and total cholesterol. Outcomes will be measured after 12, 24 and 36 months of follow-up. Trained nurses will manage the intervention group with a focus on reaching set treatment goals as soon as possible. The control group will receive usual care. At least 200 patients will be included in each group, in order to reliably detect a difference in mean systolic blood pressure of 5 mmHg. This sample size is also adequate for detection of clinically meaningful group differences in the other outcomes.

Discussion

This study will test the hypothesis that a nurse-led, long-term follow-up after stroke with a focus on reaching set treatment goals as soon as possible, is an effective secondary preventive method. If proven effective, this method could be implemented in general practice at a low cost.

Trial registration

Current Controlled Trials ISRCTN23868518

【 授权许可】

   
2013 Mooe et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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