Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000910707
Ethics application status
Approved
Date submitted
9/06/2022
Date registered
27/06/2022
Date last updated
27/06/2022
Date data sharing statement initially provided
27/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the benefits of a Nurse led Model of Asthma Care integrating Bicultural Community Healthcare Workers on asthma control in Culturally and Linguistically Diverse communities.
Scientific title
The efficacy of a Nurse led Model of Asthma Care integrating Bicultural Community Healthcare Workers on asthma control in Culturally and Linguistically Diverse communities
Secondary ID [1] 307231 0
none
Universal Trial Number (UTN)
Trial acronym
ABC_CALD Study


Asthma care encompassing Bicultural Community support within Culturally and Linguistically Diverse communities
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 326480 0
Condition category
Condition code
Respiratory 323750 323750 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An education programme delivered by an asthma nurse educator, with the support of a bicultural community health care worker as needed.
The one on one education session will be delivered, preferably in person , but may be adjusted depending on circumstance, to telehealth.
There will be an initial session at 1 week following recruitment into the study , and reinforcement by telehealth or in person at 6 weeks.
The session will be held at Western Health.
The initial session will explain how to identify signs of an asthma exacerbation and how to use a written asthma action plan. The education /training will be delivered by informal conversation. The session will be 45 minutes to 1 hour in duration.
Intervention code [1] 323718 0
Treatment: Other
Comparator / control treatment
Usual care based on Australian National Asthma Council guidelines
Control group
Active

Outcomes
Primary outcome [1] 331588 0
Asthma Control Questionnaire
Timepoint [1] 331588 0
At entry into the study and 12 weeks after leaving hospital.
Secondary outcome [1] 410351 0
percentage uptake of written asthma action plan based on a semi structured interview either in person or via telehealth.
Timepoint [1] 410351 0
12 weeks after leaving hospital.

Eligibility
Key inclusion criteria
Adults > 18 with a clinician diagnosis of asthma.
and patients from culturally and linguistically diverse communities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current smoker or ex smoker with greater than 10 pack year smoking history

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22483 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 22484 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 37718 0
3011 - Footscray
Recruitment postcode(s) [2] 37719 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 311529 0
Charities/Societies/Foundations
Name [1] 311529 0
Asthma Australia
Country [1] 311529 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
160 Gordon Street, Footscray, Vic 3011
Country
Australia
Secondary sponsor category [1] 312943 0
None
Name [1] 312943 0
Address [1] 312943 0
Country [1] 312943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310988 0
Western Health Low Risk Ethics Committee
Ethics committee address [1] 310988 0
Office for Research
Level 3 Western Health Centre for Health Research & Education – Sunshine Hospital,
Furlong Road, St Albans VIC 3021
Ethics committee country [1] 310988 0
Australia
Date submitted for ethics approval [1] 310988 0
Approval date [1] 310988 0
18/02/2022
Ethics approval number [1] 310988 0

Summary
Brief summary
This study aims to build on existing local research to trial a linguistically and culturally tailored asthma education strategy that builds on our recently established early intervention asthma nurse lead education program.

Shortly following a hospital admission, patients with asthma including those from culturally and linguistically diverse communities will be seen by a Nurse educator and a Bilingual health care worker if required for a detailed asthma education session. They will be supported by phone and in person over the next few months. Their asthma control will be assessed with a validated questionnaire at the end of the study. We hope to demonstrate that such a tailor-made programme of asthma education will improve asthma outcomes. for all patients with asthma
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119602 0
A/Prof Lata Jayaram
Address 119602 0
Western Health,
160 Gordon Street,
Footscray
Vic 3011
Country 119602 0
Australia
Phone 119602 0
+61 383957071
Fax 119602 0
Email 119602 0
[email protected]
Contact person for public queries
Name 119603 0
Lata Jayaram
Address 119603 0
Western Health,
160 Gordon Street,
Footscray
Vic 3011
Country 119603 0
Australia
Phone 119603 0
+61 383957071
Fax 119603 0
Email 119603 0
[email protected]
Contact person for scientific queries
Name 119604 0
Lata Jayaram
Address 119604 0
Western Health,
160 Gordon Street,
Footscray
Vic 3011
Country 119604 0
Australia
Phone 119604 0
+61 383957071
Fax 119604 0
Email 119604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.