Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001562864
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
17/11/2021
Date last updated
17/11/2021
Date data sharing statement initially provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The acceptability and effectiveness of a Virtual Model of Antenatal asthma Care compared to a face-to-face model of care
Scientific title
The acceptability and effectiveness of a Virtual Model of Antenatal asthma Care compared to a face-to-face model of care: A randomised controlled trial
Secondary ID [1] 305121 0
None
Universal Trial Number (UTN)
Trial acronym
A Virtual Model of Antenatal Asthma Care: The VMAC study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in pregnancy 323620 0
Condition category
Condition code
Respiratory 321154 321154 0 0
Asthma
Reproductive Health and Childbirth 321624 321624 0 0
Antenatal care
Public Health 321625 321625 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in the intervention arm will receive 2 virtual consultations on asthma management in pregnancy. These virtual consultations will use either a phone or a video platform to provide care. The consultations will cover clinical assessment (e.g., exacerbation history, asthma symptom control, triggers etc.), feedback and asthma self-management education. Each session will take approx. 30 minutes. The first session will be scheduled soon after the randomisation and provided by a nurse specialist. A respiratory physician will complete the second session within 8 weeks from the randomisation. An intervention manual will be developed to guide intervention providers, and the treatment recommendations will follow asthma guidelines. A structured asthma assessment form will be used to standardise the assessments.
Intervention code [1] 321713 0
Treatment: Other
Comparator / control treatment
Women in the control arm will receive 2 face-to-face consultations on asthma management in pregnancy. The consultations will cover clinical assessment (e.g., exacerbation history, asthma symptom control, triggers etc.), feedback and asthma self-management education. Each session will take approx. 30 minutes. The first session will be scheduled soon after the randomisation and provided by a nurse specialist. A respiratory physician will complete the second session within 8 weeks from the randomisation. Both face-to-face and virtual interventions will provide the same structured asthma care and use the same asthma assessment form.
Control group
Active

Outcomes
Primary outcome [1] 328945 0
The primary outcome will be the uptake of the model of maternal asthma care. The number of women who undertake virtual maternal asthma care (as a proportion of those allocated this care) will be compared to the number who undertake face-to-face maternal asthma care (as a proportion of those allocated this care). The intervention providers will maintain a record of participants who attended the intervention. These records will be audited to assess the uptake of the intervention.
Timepoint [1] 328945 0
Both intervention sessions will be completed within 2 months from the enrolment. The uptake of intervention by each participant will be assessed at the completion of this intervention period.
Secondary outcome [1] 400909 0
Self-reported exacerbation control during the follow-up telephone interview
Timepoint [1] 400909 0
4 months after enrolment
Secondary outcome [2] 401145 0
Self-reported asthma symptom control assessed using Asthma Control Questionnaire (ACQ-5)
Timepoint [2] 401145 0
4 months after enrolment
Secondary outcome [3] 401146 0
Feasibility and Acceptability – facilitators and barriers of implementation: qualitative interviews will be used to explore the facilitators and barriers of program implementation
Timepoint [3] 401146 0
4 months after enrolment
Secondary outcome [4] 401147 0
Intervention fidelity (i.e., the proportion of women who completed both appointments). The intervention providers will maintain a record of participants who attended the intervention. These records will be audited to assess the uptake of the intervention.

Timepoint [4] 401147 0
Both intervention sessions will be completed within 2 months from the enrolment. The Intervention fidelity for each participant will be assessed at the completion of this intervention period.
Secondary outcome [5] 402424 0
Participants’ satisfaction with the service will be assessed using Global Evaluation of Efficacy
Timepoint [5] 402424 0
4 months after enrolment

Eligibility
Key inclusion criteria
• Adult pregnant women with asthma
• Have access to a telephone
• Willing to complete baseline and follow-up telephone interviews.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to speak and understand English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
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
22/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309511 0
Government body
Name [1] 309511 0
Hunter New England Local Health District
Country [1] 309511 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Hunter New England Local Health District
Lookout Rd, New Lambton NSW 2305
Country
Australia
Secondary sponsor category [1] 310692 0
None
Name [1] 310692 0
Address [1] 310692 0
Country [1] 310692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309295 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309295 0
Ethics committee country [1] 309295 0
Australia
Date submitted for ethics approval [1] 309295 0
30/07/2021
Approval date [1] 309295 0
01/10/2021
Ethics approval number [1] 309295 0
2021/ETH11076

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

Contacts
Principal investigator
Name 113666 0
Prof Peter Gibson
Address 113666 0
The University of Newcastle
Hunter Medical Research Institute
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 113666 0
Australia
Phone 113666 0
+61 2 4042 0143
Fax 113666 0
Email 113666 0
[email protected]
Contact person for public queries
Name 113667 0
Dennis Thomas
Address 113667 0
The University of Newcastle
Hunter Medical Research Institute
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 113667 0
Australia
Phone 113667 0
+61 2 4042 0199
Fax 113667 0
Email 113667 0
[email protected]
Contact person for scientific queries
Name 113668 0
Dennis Thomas
Address 113668 0
The University of Newcastle
Hunter Medical Research Institute
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 113668 0
Australia
Phone 113668 0
+61 2 4042 0199
Fax 113668 0
Email 113668 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.