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护士协助心力衰竭患者及其家庭护理人员进行自我管理支持(SEMAPHFOR):一项随机对照试验。

Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomised controlled trial.

作者信息

Cockayne Sarah, Pattenden Jill, Worthy Gill, Richardson Gerry, Lewin Robert

机构信息

York Trials Unit, Department of Health Sciences, University of York, UK.

British Heart Foundation Care and Education Research Group, Department of Health Sciences, University of York, UK.

出版信息

Int J Nurs Stud. 2014 Sep;51(9):1207-13. doi: 10.1016/j.ijnurstu.2014.01.010. Epub 2014 Jan 22.

DOI:10.1016/j.ijnurstu.2014.01.010
PMID:24508285
Abstract

OBJECTIVE

To compare the clinical effectiveness of a newly developed cognitive behavioural self-management manual delivered by specialist heart failure nurses or the same programme followed by the patient on their own, in terms of readmissions/admissions to hospital for any reason within a 12 month period, patient health related quality of life, self-management and carer quality of life.

DESIGN

Pragmatic, open parallel group, randomised controlled trial.

SETTING

Open access heart failure diagnostic clinics and primary care.

PARTICIPANTS

260 patients with a definitive diagnosis of symptomatic heart failure (LVSD) as defined by ECHO, clinical diagnosis or coronary angiography were eligible for the study.

INTERVENTION

A newly developed nurse facilitated, cognitive behavioural self-management programme was developed and was delivered either by a heart failure nurse or by the patient on their own.

MAIN OUTCOME MEASURES

Patient admission/readmission to hospital for any reason within a 12 month period following randomisation. Secondary outcomes were: participant health related quality of life as measured by the Minnesota Living with Heart Failure questionnaire, the Hospital, Anxiety and Depression Scale, the European self-care form.

RESULTS

There was no evidence of a difference between the groups in whether or not a patient was re-admitted to hospital during the 12 month follow-up period (p=0.66). There was no evidence of a difference between the treatment groups in the mean MLHF scores over time (p=0.768), the European self-care questionnaire (p=0.340) or the mean HAD anxiety score (p=0.786). However, when adjusted for baseline scores the self-management group had a statistically significant higher HADS depression score at 12 months (p=0.003).

CONCLUSION

There was no evidence of a difference in admissions/readmission to hospital between patients who undertook a brief heart failure self-management programme facilitated by a specialist heart failure nurse and those also receiving care from a specialist nurse who followed the programme on their own.

TRIAL REGISTRATION

This trial is registered as ISRCTN84692046.

摘要

目的

比较由专业心力衰竭护士提供的新开发的认知行为自我管理手册,与患者自行遵循相同方案,在12个月内因任何原因再次入院/入院治疗方面、患者健康相关生活质量、自我管理以及照顾者生活质量的临床效果。

设计

实用、开放平行组随机对照试验。

设置

开放式心力衰竭诊断诊所和初级保健机构。

参与者

260例经超声心动图、临床诊断或冠状动脉造影确诊为有症状心力衰竭(左心室收缩功能障碍)的患者符合研究条件。

干预措施

开发了一种新的由护士协助的认知行为自我管理方案,由心力衰竭护士或患者自行实施。

主要观察指标

随机分组后12个月内患者因任何原因入院/再次入院情况。次要指标包括:用明尼苏达心力衰竭生活问卷、医院焦虑抑郁量表、欧洲自我护理表格测量的参与者健康相关生活质量。

结果

在12个月的随访期内,两组患者是否再次入院没有差异(p = 0.66)。治疗组在平均明尼苏达心力衰竭生活问卷得分随时间变化方面(p = 0.768)、欧洲自我护理问卷方面(p = 0.340)或平均医院焦虑抑郁量表焦虑得分方面(p = 0.786)均无差异。然而,在根据基线分数进行调整后,自我管理组在12个月时的医院焦虑抑郁量表抑郁得分有统计学显著升高(p = 0.003)。

结论

在由专业心力衰竭护士协助进行简短心力衰竭自我管理方案的患者与同样接受专科护士护理但自行遵循该方案的患者之间,入院/再次入院情况没有差异。

试验注册

本试验注册为ISRCTN84692046。

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