Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
NCT ID: NCT05613751
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1038 participants
INTERVENTIONAL
2022-10-26
2024-12-31
Brief Summary
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* pregnant women
* medically at risk children.
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Detailed Description
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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 by conducting four randomised control trials in
* pregnant women
* medically at risk children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* pregnant women's RCTs
* COVID-19 vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
* Influenza vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
* medically at-risk children's RCTs
* COVID-19 vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
* Influenza vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
There are eight arms in total for four RCTs.
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Pregnant women-COVID-19 vaccine RCT - intervention group
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
Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Pregnant women-COVID-19 vaccine RCT - standard care group
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.
No interventions assigned to this group
Pregnant women-influenza vaccine RCT - intervention group
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
Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Pregnant women-influenza vaccine RCT - standard care group
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.
No interventions assigned to this group
Medically at risk children-COVID-19 vaccine RCT - intervention group
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
Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Medically at risk children-COVID-19 vaccine RCT - standard care group
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.
No interventions assigned to this group
Medically at risk children-influenza vaccine RCT - intervention group
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
Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Medically at risk children-influenza vaccine RCT - standard care group
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.
No interventions assigned to this group
Interventions
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Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Eligibility Criteria
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Inclusion Criteria
* Influenza pregnant women RCT: Pregnant women have not received the influenza vaccine during pregnancy
* COVID-19 medically at risk children RCT: Medically at risk children aged 5 years to 18 years with a cardiac, endocrine, respiratory, gastrointestinal, haematological, musculoskeletal, neurological condition
* Influenza medically at risk children RCT: Children aged ≥6 months and \< 18 years with medical conditions specified in this list: immunocompromising conditions including malignancy, chronic steroid use, haematopoietic stem cell transplant; functional or anatomical asplenia including sickle cell disease or other haemoglobinopathies, congenital or acquired asplenia (for example, splenectomy) or hyposplenia; cardiac disease including cyanotic congenital heart disease, congestive heart failure, coronary artery disease; chronic respiratory conditions including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, severe asthma (requiring frequent medical consultations or the use of multiple medicines); chronic neurological conditions including hereditary and degenerative CNS diseases, seizure disorders, spinal cord injuries, neuromuscular disorders; chronic metabolic disorders including Type 1 or 2 diabetes, amino acid disorders, carbohydrate disorders, cholesterol biosynthesis disorders, fatty acid oxidation defects, lactic acidosis, mitochondrial disorders, organic acid disorders, urea cycle disorders, vitamin/cofactor disorders, porphyria; chronic renal failure; children aged 5 to 10 years receiving long term aspiring therapy; Down syndrome; obesity (body mass index ≥30 kg/m2); children born less than 37 weeks gestation
Exclusion Criteria
* Influenza pregnant women RCT: Pregnant women have contraindications to Influenza vaccines and already randomised to COVID-19 RCT.
* COVID-19 medically at risk children RCT:
* Known contraindications to COVID-19 vaccine
* Up to date for COVID-19 vaccine (≥ two doses) at the time of enrolment,
* Sibling of a child already enrolled in the trial (only the sibling who is eligible and scheduled to attend a paediatric clinic first will be eligible)
* Previous participation in the influenza nudge RCT
* Influenza medically at risk children RCT:
* Known contraindications to influenza vaccine
* Already received an influenza vaccine during the flu season in 2023
* Sibling of a child already participating in the trial (the sibling who is eligible and scheduled to attend a paediatric clinic first will be eligible)
* Previous participation in the COVID-19 nudge RCT
6 Months
ALL
No
Sponsors
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University of Adelaide
OTHER
Responsible Party
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Helen Marshall
Clinical Research Director, Women's and Children's Health Network Consultant in Vaccinology and Medical Director, Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network
Locations
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Women's and Children's Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Mercy Hospital For Women
Heidelberg, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
King Edward Memorial Hospital
Subiaco, Western Australia, Australia
Countries
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Facility Contacts
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References
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Wang B, Andraweera P, Danchin M, Blyth CC, Vlaev I, Ong J, Dodd JM, Couper J, Sullivan TR, Karnon J, Spurrier N, Cusack M, Mordaunt D, Simatos D, Dekker G, Carlson S, Tuckerman J, Wood N, Whop LJ, Marshall H. Nudging towards COVID-19 and influenza vaccination uptake in medically at-risk children: EPIC study protocol of randomised controlled trials in Australian paediatric outpatient clinics. BMJ Open. 2024 Feb 17;14(2):e076194. doi: 10.1136/bmjopen-2023-076194.
Andraweera PH, Wang B, Danchin M, Blyth C, Vlaev I, Ong J, Dodd J, Couper J, Sullivan TR, Karnon J, Spurrier N, Cusack M, Mordaunt D, Simatos D, Dekker G, Carlson S, Tuckerman J, Wood N, Whop L, Marshall HS. Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol. Trials. 2023 Jul 12;24(1):454. doi: 10.1186/s13063-023-07485-9.
Other Identifiers
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WCHN HREC/2022/HREC00082
Identifier Type: -
Identifier Source: org_study_id
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