Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000521022
Ethics application status
Approved
Date submitted
18/06/2010
Date registered
23/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Minimising Injury in Aged Care
Scientific title
Do aged care workers provided with proactive physiotherapy treatment of muscle/joint strain/weakness and psychological training to build stress resilience compared with matched workers who do not receive such support show lower levels of work-related physical and psychological injury over a 12 month period?
Secondary ID [1] 252049 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACIMS (Aged Care Injury Minimisation Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work-related physical and/or psychological injury in aged care workers 257589 0
Condition category
Condition code
Public Health 257766 257766 0 0
Health service research
Mental Health 257789 257789 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A) Physiotherapeutic Intervention
1) Professional assessment of existing (subacute) muscle and joint strain and overall physical health
2) Proactive professional managment of any subacute muscle/joint strain
3) Guidance in exercises to strengthen muscle function appropriately
B) Psychological Intervention
1) Training and advice in building strong psychosocial safety culture ( for owners and proprietors of aged care facilities)
2) Training and guidance in team leadership dynamics (shift supervisory staff)
3) Training and guidance in Stress resilience development (Other workers).

Training will occur on at least three occassions per facility over 6 months. Follow up observation for 6 months. Assessment of overt change in (objective) data of sickness absence, injury claims, return to work times, agency replacement staff costs will be provided by each participating facility and/or their WorkCover insurer (Employers Mutual Insurance (SA) for 2 years prior to the study commencement and at the study end.
Further assessment of self-report of psychological and emotional health will be made comparing baseline report at commencement of study, at 6 months and then 12 months
Intervention code [1] 256683 0
Behaviour
Intervention code [2] 256686 0
Other interventions
Intervention code [3] 256697 0
Prevention
Comparator / control treatment
Study will be undertaken at 6 separate sites.
Baseline assessments will be made of all physical and psychological parameters at commencement of the project.
In PHASE 1
Sites 1 & 2 will receive the psychological intervention only during the first 6 mths of the project
Sites 3 & 4 will receive physiotherapy intervention only during the first 6 mths of the project
Sites 5 & 6 will receive NO intervention during the first 6 mths.
In PHASE 2
ALL SITES will be reassesd across ALL parameters after 6 months; THEN;
Sites 1 & 2 will receive the physiotherapy intervention
Sites 3 & 4 will receive the psychological intervention
Sites 5 & 6 will receive BOTH interventions contemporaneously.
After 6 months
All sites will be resurveyed across all parameters
Comparison of objective data from baseline will be made.
Control group
Active

Outcomes
Primary outcome [1] 258638 0
Data on sickness absence, injury claims (costs/duration),costs of staff replacement, (aggregated to the site level), for the 2 year period prior to the study, and at the end of the study, will be provided from the data bases of a) the site itself and/or b) the data base of the sites' MediCare insurer ; Employers Mutual Insurance (SA).
Timepoint [1] 258638 0
24 months prior to study commencement, 12 months after study commencement
Primary outcome [2] 258658 0
Self report of stress experience, work demands and resources, intershift recovery, psychosocial safety culture. Data will be obtained via a self-report questionnaire.
Timepoint [2] 258658 0
Baseline, 6 months and 12 months
Primary outcome [3] 258659 0
Average return to work time for injury claims data will be obtained from the site insurer, Employers Mutual Insurance (SA)
Timepoint [3] 258659 0
baseline, 6 and 12 months
Secondary outcome [1] 264609 0
Levels of muscle and joint strength and mobility assessed by standardised physiotherapeutic protovcols
Timepoint [1] 264609 0
Baseline, after 6 and 12 months

Eligibility
Key inclusion criteria
Workers currently working in participating aged care facilities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All workers at given facilities who voluntarily agree to participate after being informed about the project both orally and in writing and who sign a consent form to that effect
All workers in given facilities will receive the same (or no) intervention as previously described
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257152 0
Commercial sector/Industry
Name [1] 257152 0
Employers Mutual Insurance Co (SA)
Country [1] 257152 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Aged Care Association of Australia (SA)
Address
Unit 5, 259 Glen Osmond Road
Frewville
SA 5063
Country
Australia
Secondary sponsor category [1] 256411 0
University
Name [1] 256411 0
University of South Australia
Address [1] 256411 0
Work & Stress Research Group
School of Psychology, Social Work and Social Policy
Magill Campus
St Bernards Road
Magill
SA 5072
Country [1] 256411 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259198 0
Human Research Ethics Committee University of South Australia
Ethics committee address [1] 259198 0
Ethics committee country [1] 259198 0
Australia
Date submitted for ethics approval [1] 259198 0
05/06/2010
Approval date [1] 259198 0
18/06/2010
Ethics approval number [1] 259198 0
0000020862

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31304 0
Address 31304 0
Country 31304 0
Phone 31304 0
Fax 31304 0
Email 31304 0
Contact person for public queries
Name 14551 0
Dr Peter C Winwood
Address 14551 0
University of South Australia
Work & Stress Research Group
Magill Campus
St Bernards Road
Magill
SA 5072
Country 14551 0
Australia
Phone 14551 0
+61883024253
Fax 14551 0
Email 14551 0
[email protected]
Contact person for scientific queries
Name 5479 0
Dr Peter C Winwood
Address 5479 0
University of South Australia
Work & Stress Research Group
Magill Campus
St Bernards Road
Magill
SA 5072
Country 5479 0
Australia
Phone 5479 0
+61883024253
Fax 5479 0
Email 5479 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.