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Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children

Primary Purpose

Influenza, COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nudge
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women (COVID RCT) - those who have received 2 or less doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have not received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 1 or no dose of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have not received the annual influenza vaccine Exclusion Criteria: Pregnant women (COVID RCT) - those who have received 3 or more doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 2 or more doses of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have received the annual influenza vaccine

Sites / Locations

  • Women's and Children's HospitalRecruiting
  • Flinders Medical CentreRecruiting
  • Lyell McEwin Hospital
  • Mercy Hospital For Women
  • The Royal Children's Hospital
  • Perth Children's Hospital
  • King Edward Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Pregnant women-COVID-19 vaccine RCT - intervention group

Pregnant women-COVID-19 vaccine RCT - standard care group

Pregnant women-influenza vaccine RCT - intervention group

Pregnant women-influenza vaccine RCT - standard care group

Medically at risk children-COVID-19 vaccine RCT - intervention group

Medically at risk children-COVID-19 vaccine RCT - standard care group

Medically at risk children-influenza vaccine RCT - intervention group

Medically at risk children-influenza vaccine RCT - standard care group

Arm Description

Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine

Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.

Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine

Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.

Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine

Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.

Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine

Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.

Outcomes

Primary Outcome Measures

The proportion of pregnant women who receive one or more doses of a COVID-19 vaccine during pregnancy
confirmed using the Australian Immunisation Register (AIR)
The proportion of pregnant women who receive one dose of the influenza vaccine during pregnancy
confirmed using the Australian Immunisation Register (AIR)
The proportion of medically at risk children who receive one or more doses of a COVID-19 vaccine
confirmed using the Australian Immunisation Register (AIR)
The proportion of medically at risk children who receive one dose of an influenza vaccine
confirmed using the Australian Immunisation Register (AIR)

Secondary Outcome Measures

Full Information

First Posted
November 10, 2022
Last Updated
November 10, 2022
Sponsor
University of Adelaide
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1. Study Identification

Unique Protocol Identification Number
NCT05613751
Brief Title
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
Official Title
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake among pregnant women and medically at risk children and test the effectiveness of the interventions using randomised controlled trials.
Detailed Description
Pregnant women and children with chronic medical conditions are at an unacceptable risk of hospitalisation and death from influenza and COVID-19 infections. Pregnant women are 3 times more likely to die from COVID-19 and over 7 times more likely to be admitted to an intensive care unit (ICU) with influenza compared to non-pregnant women. Children with chronic disease are already compromised with a higher risk of hospitalisation from influenza and requirement for ICU management and long term disability following COVID-19. Uptake of the recommended influenza vaccine among pregnant women and medically at risk children in Australia is only ~50%. Based on recent surveys, the predicted uptake of COVID-19 vaccine among both groups is also likely to be ~50%. These two groups preferentially receive care from medical specialists (obstetricians and paediatricians) and specialist nursing staff in hospitals, and are less likely to engage with primary care, the usual providers of immunisation. The aim of this project is to develop a nudge (i.e. small changes in the environment that alter people's behaviour) and evaluate the effectiveness of the nudge intervention in improving the uptake of COVID and influenza vaccine among pregnant women and medically at risk children by conducting four randomised control trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, COVID-19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregnant women-COVID-19 vaccine RCT - intervention group
Arm Type
Experimental
Arm Description
Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine
Arm Title
Pregnant women-COVID-19 vaccine RCT - standard care group
Arm Type
No Intervention
Arm Description
Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.
Arm Title
Pregnant women-influenza vaccine RCT - intervention group
Arm Type
Experimental
Arm Description
Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine
Arm Title
Pregnant women-influenza vaccine RCT - standard care group
Arm Type
No Intervention
Arm Description
Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.
Arm Title
Medically at risk children-COVID-19 vaccine RCT - intervention group
Arm Type
Experimental
Arm Description
Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine
Arm Title
Medically at risk children-COVID-19 vaccine RCT - standard care group
Arm Type
No Intervention
Arm Description
Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.
Arm Title
Medically at risk children-influenza vaccine RCT - intervention group
Arm Type
Experimental
Arm Description
Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine
Arm Title
Medically at risk children-influenza vaccine RCT - standard care group
Arm Type
No Intervention
Arm Description
Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.
Intervention Type
Behavioral
Intervention Name(s)
Nudge
Intervention Description
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Primary Outcome Measure Information:
Title
The proportion of pregnant women who receive one or more doses of a COVID-19 vaccine during pregnancy
Description
confirmed using the Australian Immunisation Register (AIR)
Time Frame
3 months of receiving the nudge intervention
Title
The proportion of pregnant women who receive one dose of the influenza vaccine during pregnancy
Description
confirmed using the Australian Immunisation Register (AIR)
Time Frame
3 months of receiving the nudge intervention
Title
The proportion of medically at risk children who receive one or more doses of a COVID-19 vaccine
Description
confirmed using the Australian Immunisation Register (AIR)
Time Frame
3 months of receiving the nudge intervention
Title
The proportion of medically at risk children who receive one dose of an influenza vaccine
Description
confirmed using the Australian Immunisation Register (AIR)
Time Frame
3 months of receiving the nudge intervention

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Pregnant women's RCT - women Medically at risk children's RCT - males and females
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women (COVID RCT) - those who have received 2 or less doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have not received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 1 or no dose of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have not received the annual influenza vaccine Exclusion Criteria: Pregnant women (COVID RCT) - those who have received 3 or more doses of a recommended COVID-19 vaccine Pregnant women (influenza RCT) - those who have received the influenza vaccine during pregnancy Medically at risk children (COVID RCT) - those who have received 2 or more doses of a recommended COVID-19 vaccine Medically at risk children(influenza RCT) - those who have received the annual influenza vaccine
Facility Information:
Facility Name
Women's and Children's Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Marshall, MBBS, MD
Phone
+61 8161 8115
Email
helen.marshall@adelaide.edu.au
First Name & Middle Initial & Last Name & Degree
Prabha Andraweera, MBBS, PhD
Phone
+61 8 8161 8117
Email
prabha.andraweera@adelaide.edu.au
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Mordaunt, FRACP
Phone
+61 8 8204 4888
Email
Dylan.Mordaunt@sa.gov.au
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gus Dekker, MD, FFANZCOG
Phone
+61 82821626
Email
gus.dekker@adelaoide.edu.au
First Name & Middle Initial & Last Name & Degree
Dimi Simatos, FRACP
Phone
+61 82821626
Email
Dimi.Simatos@sa.gov.au
Facility Name
Mercy Hospital For Women
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Danchin, FRACP
Phone
+61 3 9345 5522
Email
margie.danchin@rch.org.au
Facility Name
The Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Danchin, FRACP
Phone
T +61 3 9345 5522
Email
Margie.Danchin@rch.org.au
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Blyth, FRACP
Phone
+61 8 6456 5614
Email
christopher.blyth@uwa.edu.au
Facility Name
King Edward Memorial Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Blyth, FRACP
Phone
+61 8 6456 5614
Email
christopher.blyth@uwa.edu.au

12. IPD Sharing Statement

Learn more about this trial

Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children

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