Arthroplasty, Replacement, HipSICAMNCT02561637
The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program
A study testing Case management in people with Arthroplasty, Replacement, Hip, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Case management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
- presence at the pre-information meeting
Who cannot join
- They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs
- Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
- Index score of <6 assessed on the Charlson Comorbidity Index
About this study
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
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.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Case management, Control group
- Keywords
- Case management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementBehavioural
Control groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Case management | Experimental | Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting. Receives: Behavioral: Case management |
| Control group | Other | Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
Measured: Three months
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
Measured: Three months
Secondary outcomes (5)
Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)
Measured: Three months
Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)
Measured: Three months
Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)
Measured: Three months
Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)
Measured: Three months
Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Connie Berthelsen, University of Aarhus
- Investigators
- Connie B Berthelsen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561637
- Sponsor's protocol ID
- SICAM2015
- Acronym
- SICAM
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02561637
- Acronym / sponsor ID
- SICAM / SICAM2015
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management | Experimental | Behavioral: Case managementBefore admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting. |
| Control group | Other | Behavioral: Control groupSpouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs
- Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
- Index score of <6 assessed on the Charlson Comorbidity Index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case management | Behavioural | Case management |
| Control group | Behavioural | Control group |
Primary outcome
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
Time frame: Three months
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
Time frame: Three months
5 secondary outcomes
Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)
Time frame: Three months
Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Three months
Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)
Time frame: Three months
Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)
Time frame: Three months
Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie B Berthelsen, PhD principal investigator
University of Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with Arthroplasty, Replacement, Hip, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.