InfluenzaNCT05613751
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
A study testing Nudge in people with Influenza and COVID-19, run by University of Adelaide at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- What is being tested?
- Nudge
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,038 participants
- Where
- 7 sitesAustralia
- Study dates
- 26 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID-19 pregnant women RCT: Pregnant women have received 2 or less doses of a recommended COVID-19 vaccine
- 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
Who cannot join
- COVID-19 pregnant women RCT: Pregnant women have contraindications to COVID-19 vaccines and already randomised to influenza RCT.
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites, 7 recruiting
- Recruiting
Women's and Children's Hospital
Adelaide, South Australia, 5006
Helen Marshall, MBBS, MD, +61 8161 8115, helen.marshall@adelaide.edu.au
Prabha Andraweera, MBBS, PhD, +61 8 8161 8117, prabha.andraweera@adelaide.edu.au
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Dylan Mordaunt, FRACP, +61 8 8204 4888, Dylan.Mordaunt@sa.gov.au
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Gus Dekker, MD, FFANZCOG, +61 82821626, gus.dekker@adelaoide.edu.au
Dimi Simatos, FRACP, +61 82821626, Dimi.Simatos@sa.gov.au
- Recruiting
Mercy Hospital For Women
Heidelberg, Victoria, 3084
Margie Danchin, FRACP, +61 3 9345 5522, margie.danchin@rch.org.au
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6009
Christopher Blyth, FRACP, +61 8 6456 5614, christopher.blyth@uwa.edu.au
- Recruiting
The Royal Children's Hospital
Parkville, Victoria, 3052
Margie Danchin, FRACP, T +61 3 9345 5522, Margie.Danchin@rch.org.au
- Not yet recruiting
King Edward Memorial Hospital
Subiaco, Western Australia, 6008
Christopher Blyth, FRACP, +61 8 6456 5614, christopher.blyth@uwa.edu.au
About this study
Official title: Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
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 and test the effectiveness of the interventions using randomised controlled trials in
- pregnant women
- medically at risk children.
Read the 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 by conducting four randomised control trials in
- pregnant women
- medically at risk children.
- Being tested
- Nudge
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Three text messages that are sent four weeks apart reminding to obtain the vaccines
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women-COVID-19 vaccine RCT - intervention group | Experimental | 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 Receives: Behavioral: Nudge |
| Pregnant women-COVID-19 vaccine RCT - standard care group | No intervention | 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. |
| Pregnant women-influenza vaccine RCT - intervention group | Experimental | 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 Receives: Behavioral: Nudge |
| Pregnant women-influenza vaccine RCT - standard care group | No intervention | 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. |
| Medically at risk children-COVID-19 vaccine RCT - intervention group | Experimental | 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 Receives: Behavioral: Nudge |
| Medically at risk children-COVID-19 vaccine RCT - standard care group | No intervention | 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. |
| Medically at risk children-influenza vaccine RCT - intervention group | Experimental | 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 Receives: Behavioral: Nudge |
| Medically at risk children-influenza vaccine RCT - standard care group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR).
The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR)
The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: Within 3 months after randomisation
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR)
The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: Within 3 months after randomisation
Secondary outcomes (6)
Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics
Number of pregnant participants who received COVID-19 or influenza vaccines, change from baseline up to one month post-delivery, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR).
Measured: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Number of medically at risk children who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics
Number of medically at risk pediatric participants who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR).
Measured: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
To assess timeliness of influenza/ COVID-19 vaccine uptake among pregnant women during the study period by determining the proportion of pregnant women who receive the influenza or COVID-19 vaccine by month throughout the study period.
Timeliness of influenza and COVID-19 vaccine uptake among pregnant women during the study period will be assessed by determining the difference in proportion of pregnant women who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
To assess timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month.
Timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the difference in proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings
The incremental cost per additional person vaccinated will be assessed by comparing interventions to standard care in hospital settings. The cost per quality-adjusted life year (QALY) gained for influenza vaccination will be assessed. Implementation costs will be obtained from the study budget and costs related to research activities will be excluded. Estimated cost offsets to the health system associated with influenza related disease (e.g. hospitalisations and emergency visits) will be derived from the literature and calculated using cost weights for Australian Refined Diagnosis Related Groups (AR-DRGs).
Measured: From the date of randomisation until 46 weeks after randomisation
To determine the difference in proportion of pregnant women in intervention versus standard care arm receiving one dose of the influenza/COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
The difference in proportion of pregnant women who receive one dose of influenza/COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
Measured: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start26 Oct 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four multi-centre, parallel group, superiority, randomized control trials (with 1:1 allocation) of nudge interventions to improve influenza and COVID-19 vaccine uptake among pregnant women and medically at risk children. Each RCT will enroll 1038 participants (n = 519 each in intervention and control groups), with a total of 4154 participants in the four RCTs: * 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,038 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Marshall, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613751
- Sponsor's protocol ID
- WCHN HREC/2022/HREC00082
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38367966Andraweera 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.
PubMed 37438776
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
- ClinicalTrials.gov ID
- NCT05613751
- Acronym / sponsor ID
- WCHN HREC/2022/HREC00082
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,038 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and test the effectiveness of the interventions using randomised controlled trials in
- pregnant women
- medically at risk children.
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 by conducting four randomised control trials in
- pregnant women
- medically at risk children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- Model description
- Four multi-centre, parallel group, superiority, randomized control trials (with 1:1 allocation) of nudge interventions to improve influenza and COVID-19 vaccine uptake among pregnant women and medically at risk children. Each RCT will enroll 1038 participants (n = 519 each in intervention and control groups), with a total of 4154 participants in the four RCTs: * 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.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women-COVID-19 vaccine RCT - intervention group | Experimental | Behavioral: NudgeWomen 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 |
| Pregnant women-COVID-19 vaccine RCT - standard care group | No intervention | –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. |
| Pregnant women-influenza vaccine RCT - intervention group | Experimental | Behavioral: NudgeWomen randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine |
| Pregnant women-influenza vaccine RCT - standard care group | No intervention | –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. |
| Medically at risk children-COVID-19 vaccine RCT - intervention group | Experimental | Behavioral: NudgeParents 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 |
| Medically at risk children-COVID-19 vaccine RCT - standard care group | No intervention | –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. |
| Medically at risk children-influenza vaccine RCT - intervention group | Experimental | Behavioral: NudgeParents 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 |
| Medically at risk children-influenza vaccine RCT - standard care group | No intervention | –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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- COVID-19 pregnant women RCT: Pregnant women have received 2 or less doses of a recommended COVID-19 vaccine
- 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
Key exclusion criteria (12 listed)
- COVID-19 pregnant women RCT: Pregnant women have contraindications to COVID-19 vaccines and already randomised to influenza RCT.
- 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:
- Influenza medically at risk children RCT:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NudgeThree text messages that are sent four weeks apart reminding to obtain the vaccines | Behavioural | Medically at risk children-COVID-19 vaccine RCT - intervention group, Medically at risk children-influenza vaccine RCT - intervention group, Pregnant women-COVID-19 vaccine RCT - intervention group, Pregnant women-influenza vaccine RCT - intervention group |
Primary outcome
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR).
Time frame: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR)
Time frame: Within 3 months after randomisation
The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
Time frame: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR)
Time frame: Within 3 months after randomisation
The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).
6 secondary outcomes
Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics
Time frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Number of medically at risk children who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics
Time frame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
To assess timeliness of influenza/ COVID-19 vaccine uptake among pregnant women during the study period by determining the proportion of pregnant women who receive the influenza or COVID-19 vaccine by month throughout the study period.
Time frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
To assess timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month.
Time frame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings
Time frame: From the date of randomisation until 46 weeks after randomisation
To determine the difference in proportion of pregnant women in intervention versus standard care arm receiving one dose of the influenza/COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
Time frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 38367966Wang 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.
- Derived from this study: PubMed 37438776Andraweera 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.
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Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge in people with Influenza and COVID-19, run by University of Adelaide at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR). (time frame: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.