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Trial registered on ANZCTR


Registration number
ACTRN12617000729325
Ethics application status
Approved
Date submitted
11/05/2017
Date registered
19/05/2017
Date last updated
25/11/2019
Date data sharing statement initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Levels of distress and anxiety in patients after trauma and their next-of-kin while in hospital
Scientific title
Levels of distress and anxiety in acute trauma patients and their next-of-kin throughout the period of hospitalisation
Secondary ID [1] 291918 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
trauma 303242 0
intensive care 303243 0
Mental health 303343 0
Condition category
Condition code
Injuries and Accidents 302666 302666 0 0
Other injuries and accidents
Mental Health 302772 302772 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No aspect of usual care will be changed as a result of the current study. In particular, social work assessment and interventions will be provided as per usual practice. Participation in this study will involve completing two 'questionnaires'. One will take approximately 30 seconds to complete and the other 5 to 10 minutes. The questionnaires will be completed three times: once as soon as possible post-admission to hospital, then on transfer to a general ward and then just prior to hospital discharge. The duration of the observation period will be variable depending on the length of hospital stay.
Intervention code [1] 298040 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302070 0
Subjective Units of Distress Scale
Timepoint [1] 302070 0
As soon as possible after hospital admission, after transfer to the general ward and a few days prior to hospital discharge.
Primary outcome [2] 302071 0
Depression Anxiety and Stress Scale (21 items)
Timepoint [2] 302071 0
As soon as possible after hospital admission, after transfer to the general ward and a few days prior to hospital discharge.
Secondary outcome [1] 334680 0
Amount of social work intervention (total number of interventions and total duration of interventions). These data will be retrieved from databases already in use where allied health interventions, including social work, are recorded.
Timepoint [1] 334680 0
Throughout hospital admission.

Eligibility
Key inclusion criteria
All patients admitted to the Intensive Care Unit of the Royal Adelaide Hospital following trauma under the auspices of the Acute Surgical Unit or Neurosurgery Department who are referred for social work assessment and intervention, and their next-of-kin who is visiting the patient (i.e. not involved in the traumatic injury).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients or next-of-kin who refuse consent or are unable to communicate effectively and easily in English (e.g. insufficient understanding of English, cognitive impairment, psychiatric condition). In the clinical scenario where the patient is unable to communicate as a result of their traumatic injury, or the treatment thereof, the patient’s next-of-kin will be invited to participate in the study and the patient only approached regarding participation once they are able to communicate effectively in English.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Most analyses will be descriptive in nature. Data will be reviewed to identify factors associated with anxiety and distress.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2017
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7988 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 15965 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296424 0
Self funded/Unfunded
Name [1] 296424 0
Country [1] 296424 0
Primary sponsor type
Individual
Name
Kathy Stiller
Address
Level 4 Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 295374 0
Individual
Name [1] 295374 0
Manoj Pereira
Address [1] 295374 0
Social Work Department
L5 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 295374 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297651 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 297651 0
Ethics committee country [1] 297651 0
Australia
Date submitted for ethics approval [1] 297651 0
Approval date [1] 297651 0
05/05/2017
Ethics approval number [1] 297651 0
HREC/17/RAH/107

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

Contacts
Principal investigator
Name 74710 0
Dr Kathy Stiller
Address 74710 0
L4 Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 74710 0
Australia
Phone 74710 0
+61 8 82225334
Fax 74710 0
Email 74710 0
Kathy.Stiller@sa.gov.au
Contact person for public queries
Name 74711 0
Kathy Stiller
Address 74711 0
L4 Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 74711 0
Australia
Phone 74711 0
+61 8 82225334
Fax 74711 0
Email 74711 0
Kathy.Stiller@sa.gov.au
Contact person for scientific queries
Name 74712 0
Kathy Stiller
Address 74712 0
L4 Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 74712 0
Australia
Phone 74712 0
+61 8 82225334
Fax 74712 0
Email 74712 0
Kathy.Stiller@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.