Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000673842
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
3/06/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Care from Home program: a comprehensive community-based care coordination for management of paediatric asthma (CoMPAs) project
Scientific title
Care from Home program: effect of a comprehensive community-based care coordination for management of paediatric asthma (CoMPAs) project on health care utilisation
Secondary ID [1] 303738 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 321185 0
Condition category
Condition code
Respiratory 318977 318977 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions of this study will be implemented over a period of 12 months. Each participating child will be provided with the following interventions after discharged from asthma-related hospitalizations:
1. Asthma resource package which will include: (a) copy of "Asthma and Your child: a resource pack for parents and carers" developed by the Aiming for Asthma Improvement in Children (AAIC) team at the Sydney Children's Hospital Randwick. It contains the standardized asthma information aimed at improving parent's/carer's understanding of asthma e.g. symptom recognition, basic physiology of asthma etc; (b) a letter for the general practitioner (GP) informing them of the child's recent hospital visits and clinical best practice and clinical asthma management tips; (c) a letter for school or childcare services informing them of the child's asthma-related hospitalizations and provided access to online options on asthma management training for school/childcare staff; (d) individualized asthma action plan completed by the treating doctor at the hospital; (e) written discharge instructions for parents/carers which will include recommendation for medical follow-up with a GP or paediatrician within 3 days after discharged from the hospital, advice to receive influenza vaccine, information on access to the Asthma Australia Helpline and link to online free asthma education sessions. The Asthma resource package will be given to patients or their parents/carers upon their discharge by the hospital staff.
2. After the participants were discharged from the hospital, the care coordinator of the research team will email discharge instructions and clinical best practice asthma tips to the respective primary care providers/GPs.
3. An automated reminder text message will be sent to the parents/carers every 3 months post-discharge by the care coordinator, advising them of regular medical follow-up of their child with the GP and providing link to free asthma education webinar sessions and access to Asthma Australia Helpline.
4. A virtual home visits of 45-60 minutes will be carried out by the care coordinator using encrypted digital platform such as WhatsApp, FaceTime etc. within 3 months post-hospitalization to assess home environmental triggers and respond to parent/carer concerns relating to the child's asthma management plan.
5. Care coordinator will coordinate with GPs and facilitate a follow-up consultation for the child within 3-5 days after discharge from the hospital.
6. Care coordinator will email the school/childcare services of the participating child to ensure that they are aware of the child's recent asthma hospital presentation and have updated School & Child Services Action Plan for Asthma Flare up and school/childcare staff will have access to online first aid asthma management training.
Attendance to online sessions will be self-reporting and collected in the final survey of the study.
Intervention code [1] 320049 0
Prevention
Intervention code [2] 320478 0
Treatment: Other
Comparator / control treatment
Control group will receive routine discharge care (i.e. usually only prescription and discharge summary are provided to the parents/carers and no further care e.g. home visits or education will be provided by the hospital once they are discharged from the hospital).
Also, they will receive the same "asthma resource package" that was given to the intervention group upon their hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 326894 0
Number of ED visits in the preceding 6 months as assessed by study-specific, self-reporting questionnaire.
Timepoint [1] 326894 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Primary outcome [2] 326895 0
Number of hospital admissions in the preceding 6 months as assessed by study-specific,self-reporting questionnaire.
Timepoint [2] 326895 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Primary outcome [3] 326896 0
Number of GP clinic visits in the preceding 6 months as assessed by study-specific, self-reporting questionnaire.
Timepoint [3] 326896 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [1] 393035 0
Asthma control score as measured by Asthma Control Questionnaire (ACT) or Childhood Asthma Control test (C-ACT) questionnaire
Timepoint [1] 393035 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [2] 393036 0
Quality of life as measured by mini Paediatric Asthma Quality of Life Questionnaire (miniPAQLQ)
Timepoint [2] 393036 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [3] 393037 0
Number of days missed from school by the child in the preceding 6 months as assessed by study-specific, self-reporting questionnaire.
Timepoint [3] 393037 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [4] 393038 0
Number of days missed from work by parents/carers due to their child's asthma in the preceding 6 months, as assessed by study-specific,self-reporting questionnaire
Timepoint [4] 393038 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [5] 393039 0
Level of parental satisfaction with the intervention (intervention group only) as assessed by a study-specific self-reporting evaluation questionnaire.
Timepoint [5] 393039 0
This questionnaire will be administered at 12-month after participants enrolled in the study.
Secondary outcome [6] 395097 0
Number of days requiring oral corticosteroid e.g prednisone in the preceding 6 months, as assessed by study-specific, self-reporting questionnaire.
Timepoint [6] 395097 0
Questionnaire will be administered at baseline, 6-month and 12-month after participants enrolled in the study.
Secondary outcome [7] 395098 0
Number of days of asthma-related activity limitations of the child in the preceding 14 days, as assessed by study-specific,self-reporting questionnaire.
Timepoint [7] 395098 0
Questionnaire will be administered at baseline, 6-month and 12-month time after participants enrolled in the study.

Eligibility
Key inclusion criteria
Key inclusion criteria are:
- Children aged between 5-16 years old.
- Children with any ED visits or hospital admission for asthma/VIW-related illnesses
- Children attended ED or admitted to general paediatric ward at the Liverpool Hospital during the study period.
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
• Children with complex conditions e.g., genetic disorders, complex cardiac diseases etc.
• Children with significant developmental delays or comorbidities that will significantly limit their ability to participate in the study
• Children admitted to intensive care unit (ICU)
• Parents/carers who are not fluent in English
• Families who do not have permanent housing e.g. lived in a shelter

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization with a block size of 6
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the data from previous study on hospital visits with mean difference of 0.53 and standard deviation of 1.34, a sample size of 100 per arm will be needed to ensure 80% power with 95% confidence interval and 0.05 significance level for a two-sided test.
Descriptive statistics such as mean, median, standard deviation and frequency will be calculated, where appropriate. Outcome measurements will be repeated at 3 time points (0, 6, and 12-month time). Comparisons will be assessed between control and intervention group, as well as over time. Differences between groups will be assessed using student’s t tests for continuous variables and X2 tests for categorical variables. For ranked data, Mann Whitney U tests will be used to test for between group differences with non-parametric distribution. Generalized estimating equations (GEE) will be used to evaluate the changes of individual outcome over time after accounting for the dependence of repeated observations within each subject. All statistical analyses will be performed using IBM SPSS Statistics 24 for Windows with two-sided tests at 5% level of significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2022
Actual
22/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18948 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 33456 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 308145 0
Charities/Societies/Foundations
Name [1] 308145 0
Asthma Australia
Country [1] 308145 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St, Kensington, NSW 2052
Country
Australia
Secondary sponsor category [1] 308910 0
None
Name [1] 308910 0
Address [1] 308910 0
Country [1] 308910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308131 0
Sydney Children's Hospitals Network Ethics Committee
Ethics committee address [1] 308131 0
Ethics committee country [1] 308131 0
Australia
Date submitted for ethics approval [1] 308131 0
29/04/2021
Approval date [1] 308131 0
18/01/2022
Ethics approval number [1] 308131 0

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

Contacts
Principal investigator
Name 109646 0
Dr Nusrat Homaira
Address 109646 0
School of Women's and Childrens Health
University of NSW
Level 8, Bright Alliance Building,
cnr of Avoca and High St
Randwick NSW 2031
Country 109646 0
Australia
Phone 109646 0
+61 2 9382 5526
Fax 109646 0
Email 109646 0
[email protected]
Contact person for public queries
Name 109647 0
Nusrat Homaira
Address 109647 0
School of Women's and Children's Health
University of NSW
Level 8, Bright Alliance Building,
cnr of Avoca and High St
Randwick NSW 2031
Country 109647 0
Australia
Phone 109647 0
+61 2 9382 5526
Fax 109647 0
Email 109647 0
[email protected]
Contact person for scientific queries
Name 109648 0
Nusrat Homaira
Address 109648 0
School of Women's and Children's Health
University of NSW
Level 8, Bright Alliance Building,
cnr of Avoca and High St
Randwick NSW 2031
Country 109648 0
Australia
Phone 109648 0
+61 2 9382 5526
Fax 109648 0
Email 109648 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
Insufficient funding


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.