The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program (SICAM)
2015年9月25日 更新者：Connie Berthelsen、University of Aarhus
The SICAM-trial: Studying the Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program During and After Total Hip Replacement - A Quasi-experimental Study With a Complex Intervention
Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation.
Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role.
The aim of this study is to investigate the effect of spouses' involvement in older patients fast-track treatment programs using case management as intervention.
A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012) was used.
Patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses was recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control group (n=14).
Data was collected from both groups at baseline, two weeks and three months after surgery.
Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.
研究概览
研究类型
介入性
注册 (实际的)
58
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria: Patients
- 65 years of age or older
- undergoing a total hip replacement due to arthritis
- live with their spouses
- speak, read and understand Danish without an interpreter
- have their spouses present at the mandatory pre-information meeting in the outpatient facilities.
Inclusion Criteria: Spouses
- presence at the pre-information meeting
Exclusion Criteria: Patients
- They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs
Exclusion criteria: Both
- Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
- Index score of <6 assessed on the Charlson Comorbidity Index
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Case management
Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan.
During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals.
During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan.
After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting.
|
|
|
其他：Control group
Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff.
The usual care and information is provided before admission in the out-patient facilities and during admission
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
大体时间：Three months
|
Three months
|
|
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
大体时间：Three months
|
Three months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)
大体时间：Three months
|
Three months
|
|
Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)
大体时间：Three months
|
Three months
|
|
Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)
大体时间：Three months
|
Three months
|
|
Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)
大体时间：Three months
|
Three months
|
|
Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale
大体时间：Three months
|
Three months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Connie B Berthelsen, PhD、University of Aarhus
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年8月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2015年9月21日
首先提交符合 QC 标准的
2015年9月25日
首次发布 (估计)
2015年9月28日
研究记录更新
最后更新发布 (估计)
2015年9月28日
上次提交的符合 QC 标准的更新
2015年9月25日
最后验证
2015年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- SICAM2015
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案例管理的临床试验
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