Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000839606
Ethics application status
Approved
Date submitted
16/07/2014
Date registered
7/08/2014
Date last updated
7/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Implementation Project to Improve Identification Of Altered Mood for People Hospitalised After Acute Stroke
Scientific title
Will patients with acute stroke who are admitted to a hospital providing the mood identification program have a greater likelihood of having altered mood identified than patients in hospitals providing standard care and when compared to an historical control period?
Secondary ID [1] 284000 0
Nil
Universal Trial Number (UTN)
Trial acronym
IAMAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 291037 0
Condition category
Condition code
Stroke 291375 291375 0 0
Ischaemic
Stroke 291376 291376 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with stroke and TIA admitted to intervention sites will be observed (from admission onwards) and screened (after 5 days) for altered mood. Screening will be undertaken using the Hospital Anxiety & Depression Scale (HADS) or for those with cognition/ communication issues the Behavioural Outcomes of Anxiety (BOA) and Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H10) tools. These will be repeated as clinically indicated. Staff will be trained in observation and screening. Evidence of identification of altered mood, including screen scores, will be recorded in the medical record.
Intervention code [1] 288688 0
Early detection / Screening
Comparator / control treatment
The National Stroke Foundation Audit data from 2011 and 2013 will be used as historical comparative data for both Intervention and Control sites.
Both groups will also undertake a prospective, pre-implementation file audit for all patients admitted with stroke or TIA over a 5 week period.
The intervention will then be implemented at the Intervention sites, while the Control sites will continue with business as usual. No changes regarding identify altered mood will be trialled at these sites.
A repeat of the file audit will be undertaken at Intervention and Control sites 5 months after commencing the intervention.
Control group
Active

Outcomes
Primary outcome [1] 291369 0
Percentage of patients with stroke who have consideration of altered mood documented in their medical record
Timepoint [1] 291369 0
At discharge
Secondary outcome [1] 306615 0
Percentage of patients with stroke with a length of stay greater than or equal to 5 days who have undergone a screening of anxiety and depression
Timepoint [1] 306615 0
At discharge
Secondary outcome [2] 309361 0
Percentage of intervention sites that have an identified individual/ s responsible for leading altered mood identification
Timepoint [2] 309361 0
At commencement of intervention program

Eligibility
Key inclusion criteria
Admitted with clinical signs of stroke or Transient Ischaemic Attack (TIA)
Participants located in a stroke unit or general ward
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study is investigating the effectiveness of an implementation strategy to improve identification of altered mood after stroke.
It is a nonrandomised intervention comparison study with retrospective and prospective control groups (historical-control for within hospital change) and prospective control cohort (similar hospitals not providing the intervention)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics exploring differences in proportions for adherence to providing mood assessments (n adherence/ N eligible patients) using the Chi 2 test. Bivariable and multivariable regression analyses to assess for associations of patient or hospital characteristics with the likelihood of receiving a mood assessment with adjustment for patient clustering by hospital and differences in patient case-mix.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/05/2014
Actual
19/05/2014
Date of last participant enrolment
Anticipated
24/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2011 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 2012 0
The Maitland Hospital - Maitland
Recruitment hospital [3] 2013 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 2014 0
Belmont Hospital - Belmont
Recruitment hospital [5] 2015 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [6] 2016 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [7] 2017 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [8] 2018 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [9] 2019 0
Gosford Hospital - Gosford
Recruitment hospital [10] 2020 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 7726 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 7727 0
2320 - Maitland
Recruitment postcode(s) [3] 8431 0
2298 - Waratah
Recruitment postcode(s) [4] 8432 0
2280 - Belmont
Recruitment postcode(s) [5] 8433 0
2430 - Taree
Recruitment postcode(s) [6] 8434 0
2350 - Armidale
Recruitment postcode(s) [7] 8435 0
2340 - Tamworth
Recruitment postcode(s) [8] 8436 0
2444 - Port Macquarie
Recruitment postcode(s) [9] 8437 0
2250 - Gosford
Recruitment postcode(s) [10] 8439 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 288627 0
Charities/Societies/Foundations
Name [1] 288627 0
National Stroke Foundation
Country [1] 288627 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Rd,
New Lambton Heights,
NSW. 2305.
Country
Australia
Secondary sponsor category [1] 287334 0
Government body
Name [1] 287334 0
Central Coast Local Health District
Address [1] 287334 0
Gosford Hospital
Holden Street
GOSFORD NSW 2250
Country [1] 287334 0
Australia
Secondary sponsor category [2] 287335 0
Government body
Name [2] 287335 0
North Coast Local Health District
Address [2] 287335 0
Morton Street
PORT MACQUARIE NSW 2444
Country [2] 287335 0
Australia
Other collaborator category [1] 278050 0
University
Name [1] 278050 0
Monash University
Address [1] 278050 0
Wellington Rd, Clayton VIC 3800
Country [1] 278050 0
Australia
Other collaborator category [2] 278051 0
University
Name [2] 278051 0
University of Western Sydney
Address [2] 278051 0
Hawkesbury Campus, College Dr, Richmond, NSW 2753
Country [2] 278051 0
Australia
Other collaborator category [3] 278052 0
Charities/Societies/Foundations
Name [3] 278052 0
Hunter Medical Research Institute
Address [3] 278052 0
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [3] 278052 0
Australia
Other collaborator category [4] 278053 0
Charities/Societies/Foundations
Name [4] 278053 0
National Stroke Foundation
Address [4] 278053 0
Level 7, 461 Bourke St
Melbourne. Victoria. 3000
Country [4] 278053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290485 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290485 0
Ethics committee country [1] 290485 0
Australia
Date submitted for ethics approval [1] 290485 0
29/11/2013
Approval date [1] 290485 0
17/12/2013
Ethics approval number [1] 290485 0
13/12/11/4.01

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

Contacts
Principal investigator
Name 45894 0
Ms Di Marsden
Address 45894 0
Hunter Stroke Service,
Level 2 , The Lodge
Rankin Park Campus,
Lookout Road,
New Lambton Heights.
NSW. 2305.
Country 45894 0
Australia
Phone 45894 0
+61 2 49223380
Fax 45894 0
Email 45894 0
[email protected]
Contact person for public queries
Name 45895 0
Di Marsden
Address 45895 0
Hunter Stroke Service,
Level 2 , The Lodge
Rankin Park Campus,
Lookout Road,
New Lambton Heights.
NSW. 2305.
Country 45895 0
Australia
Phone 45895 0
+61 2 49223380
Fax 45895 0
Email 45895 0
[email protected]
Contact person for scientific queries
Name 45896 0
Di Marsden
Address 45896 0
Hunter Stroke Service,
Level 2 , The Lodge
Rankin Park Campus,
Lookout Road,
New Lambton Heights.
NSW. 2305.
Country 45896 0
Australia
Phone 45896 0
+61 2 49223380
Fax 45896 0
Email 45896 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
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