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Completed

NCT Number: NCT02561637

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case Management

Behavioral

Control Group

Behavioral

Primary outcomes

  1. Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale

    Time frame: Three months

  2. Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)

    Time frame: Three months

Secondary outcomes

  1. Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)

    Time frame: Three months

  2. Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: Three months

  3. Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)

    Time frame: Three months

  4. Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)

    Time frame: Three months

  5. Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale

    Time frame: Three months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Lund University

Registry information

Official study 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

Acronym: SICAM

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2015
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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