Clinical trial NCT02561637: The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Case management
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2015-09-28
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
timeFrame: Three months
measure: Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
timeFrame: Three months
Secondary outcomes:
measure: Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)
timeFrame: Three months
measure: Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Three months
measure: Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)
timeFrame: Three months
measure: Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)
timeFrame: Three months
measure: Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale
timeFrame: Three months
Other outcomes:
Locations:
Study officials:
affiliation: University of Aarhus
name: Connie B Berthelsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: