The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program

Arthroplasty, Replacement, Hip Clinical Trial

— SICAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561637
• Other study ID #: SICAM2015
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: September 25, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Behavioral:
• Case management

• Control group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale		Three months	No
Primary	Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)		Three months	No
Secondary	Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)		Three months	No
Secondary	Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)		Three months	No
Secondary	Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)		Three months	No
Secondary	Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)		Three months	No
Secondary	Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale		Three months	No