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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
时间窗: Three months
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
时间窗: Three months
次要结局
- Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)(Three months)
- Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)(Three months)
- Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)(Three months)
- Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale(Three months)
- Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)(Three months)
研究者
Connie Berthelsen
Assistant professor
University of Aarhus