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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02561637
Acronym
SICAM
Enrollment
58
Registered
2015-09-28
Start date
2014-08-31
Completion date
2015-06-30
Last updated
2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Hip

Keywords

Case management

Brief 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.

Interventions

BEHAVIORALCase management
BEHAVIORALControl group

Sponsors

Lund University
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scaleThree months
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)Three months

Secondary

MeasureTime frame
Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)Three months
Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)Three months
Anxiety assessed using the Generalized anxiety disorder (GAD-7) scaleThree months
Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)Three months
Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)Three months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026