Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
Study NCT ID:
NCT06815250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhancing Maternal Vaccine Knowledge and Uptake: the InTroDuce-Programme Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'web-based educational video on Influenza and Tdap vaccine (InTroDuce-Programme)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 351}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of Influenza and Tdap Vaccination', 'timeFrame': '1 month post-intervention', 'description': 'knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire'}, {'measure': 'Vaccination Future Uptake', 'timeFrame': '1 month post-intervention', 'description': 'Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire'}], 'secondaryOutcomes': [{'measure': 'Barriers to vaccination uptake', 'timeFrame': '1 month post-intervention', 'description': 'Identification of barriers to vaccination uptake and socio-demographic factors influencing outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza vaccination', 'Tdap vaccination', 'Educational module', 'Pregnant mothers', 'Vaccine knowledge', 'Vaccine uptake'], 'conditions': ['Vaccination Uptake', 'Knowledge', 'Tetanus, Diphtheria and Acellular Pertussis Vaccination', 'Influenza', 'Web Based Intervention', 'Vaccine Knowledge']}, 'referencesModule': {'references': [{'pmid': '31471001', 'type': 'BACKGROUND', 'citation': "O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27."}, {'pmid': '29649195', 'type': 'BACKGROUND', 'citation': 'Deverall EJ, Gilmore B, Illing S, Peiris-John R. Pertussis vaccination uptake in pregnancy: lessons to be learned from an integrated healthcare approach. N Z Med J. 2018 Apr 13;131(1473):42-47.'}, {'pmid': '33129424', 'type': 'BACKGROUND', 'citation': 'Dawood FS, Kittikraisak W, Patel A, Rentz Hunt D, Suntarattiwong P, Wesley MG, Thompson MG, Soto G, Mundhada S, Arriola CS, Azziz-Baumgartner E, Brummer T, Cabrera S, Chang HH, Deshmukh M, Ellison D, Florian R, Gonzales O, Kurhe K, Kaoiean S, Rawangban B, Lindstrom S, Llajaruna E, Mott JA, Saha S, Prakash A, Mohanty S, Sinthuwattanawibool C, Tinoco Y. Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study. Lancet Infect Dis. 2021 Jan;21(1):97-106. doi: 10.1016/S1473-3099(20)30592-2. Epub 2020 Oct 29.'}, {'pmid': '34544209', 'type': 'BACKGROUND', 'citation': 'Hong EY, Kulkarni K, Gosavi A, Wong HC, Singh K, Kale AS. Assessment of knowledge and attitude towards influenza and pertussis vaccination in pregnancy and factors affecting vaccine uptake rates: a cross-sectional survey. Singapore Med J. 2023 Aug;64(8):513-516. doi: 10.11622/smedj.2021097. No abstract available.'}, {'pmid': '37934788', 'type': 'BACKGROUND', 'citation': 'Razai MS, Mansour R, Goldsmith L, Freeman S, Mason-Apps C, Ravindran P, Kooner P, Berendes S, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Interventions to increase vaccination against COVID-19, influenza and pertussis during pregnancy: a systematic review and meta-analysis. J Travel Med. 2023 Dec 28;30(8):taad138. doi: 10.1093/jtm/taad138.'}, {'pmid': '32645112', 'type': 'BACKGROUND', 'citation': 'Kilich E, Dada S, Francis MR, Tazare J, Chico RM, Paterson P, Larson HJ. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. PLoS One. 2020 Jul 9;15(7):e0234827. doi: 10.1371/journal.pone.0234827. eCollection 2020.'}, {'pmid': '28459427', 'type': 'BACKGROUND', 'citation': 'Racicot K, Mor G. Risks associated with viral infections during pregnancy. J Clin Invest. 2017 May 1;127(5):1591-1599. doi: 10.1172/JCI87490. Epub 2017 May 1.'}, {'pmid': '33773923', 'type': 'BACKGROUND', 'citation': 'Arora M, Lakshmi R. Vaccines - safety in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021 Oct;76:23-40. doi: 10.1016/j.bpobgyn.2021.02.002. Epub 2021 Feb 19.'}, {'pmid': '36182617', 'type': 'BACKGROUND', 'citation': "Merdrignac L, Acosta L, Habington A, Garcia Cenoz M, Pandolfi E, Fabianova K, Jordan I, O'Sullivan N, Navasues A, Tozzi AE, Zavadilova J, Jane M, Cotter S, Pitillas NI, Rizzo C, Krizova P, Hanslik T, Munoz Almagro C, Pastore L, Bacci S, Moren A, Valenciano M; PERTINENT Group. Effectiveness of pertussis vaccination in pregnancy to prevent hospitalisation in infants aged <2 months and effectiveness of both primary vaccination and mother's vaccination in pregnancy in infants aged 2-11 months. Vaccine. 2022 Oct 19;40(44):6374-6382. doi: 10.1016/j.vaccine.2022.09.054. Epub 2022 Sep 29."}, {'pmid': '38640190', 'type': 'BACKGROUND', 'citation': 'Razai MS, Mansour R, Ravindran P, Freeman S, Mason-Apps C, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Facilitators and barriers to vaccination uptake in pregnancy: A qualitative systematic review. PLoS One. 2024 Apr 19;19(4):e0298407. doi: 10.1371/journal.pone.0298407. eCollection 2024.'}, {'pmid': '34016653', 'type': 'BACKGROUND', 'citation': 'Razai MS, Chaudhry UAR, Doerholt K, Bauld L, Majeed A. Covid-19 vaccination hesitancy. BMJ. 2021 May 20;373:n1138. doi: 10.1136/bmj.n1138. No abstract available.'}, {'pmid': '34164686', 'type': 'BACKGROUND', 'citation': 'Parsons J, Griffiths SE, Thomas N, Atherton H. How effective are digital interventions in increasing flu vaccination among pregnant women? A systematic review and meta-analysis. J Public Health (Oxf). 2022 Dec 1;44(4):863-876. doi: 10.1093/pubmed/fdab220.'}], 'seeAlsoLinks': [{'url': 'https://www.cdc.gov/vaccines-pregnancy/about/index.html', 'label': 'Centers for Disease Control and Prevention (CDC). (2023). Vaccination During Pregnancy'}, {'url': 'https://hq.moh.gov.my/bpkk/images/PERINATAL_CARE_MANUAL_4th_Edition_2020_11Mei2023.pdf', 'label': 'PERINATAL CARE MANUAL 4th EDITION. Ministry of Health. 2022'}]}, 'descriptionModule': {'briefSummary': "The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:\n\nDoes the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?\n\nResearchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:\n\nReceive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.\n\nBe followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated", 'detailedDescription': "1.0 Background and Significance\n\nMaternal vaccination is a crucial public health strategy to protect mothers and infants from infectious diseases like influenza and pertussis. Pregnant women face higher risks of complications due to physiological and immunological changes, with a fourfold increased likelihood of influenza-related hospitalization. Similarly, pertussis is particularly severe in infants under two months. In Malaysia, the Ministry of Health recommends influenza and Tdap vaccines during pregnancy, but uptake remains low due to safety concerns, limited provider recommendations, and access issues. Digital interventions, particularly video-based education, have shown promise in addressing vaccine hesitancy. To tackle these barriers, the InTroDuce-Programme, a comprehensive web-based educational module, has been developed to improve vaccination knowledge and uptake.\n\n2.0 Objective\n\nGeneral objective: To evaluate the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.\n\nSpecific objectives:\n\n1. To determine the sociodemographic factors and clinical variables among study population.\n2. To determine the prevalence of future vaccination uptake following the InTroDuce-Programme.\n3. To evaluate the level of participants' attitudes and barriers towards future vaccination uptake before and after the InTroDuce-Programme.\n4. To determine the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.\n5. To determine the factors associated with low future uptake of vaccine with socio-demographic factors (age, race, income, education) among pregnant mothers.\n\n3.0 Methodology\n\n3.1 Study Design\n\nThis randomised controlled trial (RCT) will be conducted in four primary care clinics in Hulu Langat district which are Klinik Kesihatan Kajang, Klinik Kesihatan Bangi, Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong. The study duration is 12 months, with recruitment over 6 months. A second follow-up will be conducted one month after providing the InTroDuce-Programme. Two clinics will be randomly assigned to administer the InTroDuce-Programme, while the other two will be provided with standard care, in order to minimise contamination.\n\nCluster definition based on urban and suburban classification Klinik Kesihatan Kajang and Klinik Kesihatan Bangi are classified as urban, while Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong are classified as suburban. These clinics were selected due to their geographic and demographic similarity, coupled with variability in socioeconomic, educational, cultural, and attitudinal factors. This selection ensures a balanced representation of diverse populations, enhancing the generalizability and applicability of the study findings. The approach is particularly valuable for comprehensively understanding the factors that influence vaccine knowledge and uptake among pregnant mothers.\n\nRandom Allocation of Clinics Random Assignment: One clinic from each category (urban and suburban) will be randomly assigned to either the intervention or control group using an online random number generator. This method ensures unbiased allocation and maintains the balance of geographic representation in both groups.\n\nThe rationale for Randomization is to minimise contamination. Randomizing at the clinic level (cluster randomization) rather than at the individual level will help reduce the risk of contamination, where participants in the same clinic may share information or influence each other's behaviour. By assigning entire clinics to either intervention or control, the study ensures that participants within each clinic receive consistent and isolated exposure to the educational materials or standard care.\n\n3.2 Sample Size\n\nThe sample size is 351 participants, accounting for a 20% non-response rate. This is based on expected uptake rates of 55% in the intervention group and 36% in the control group.\n\n3.3 Data Collection\n\nA validated, adapted questionnaire will be used in this study to assess vaccine-related knowledge, attitudes, future uptake intentions, and factors influencing vaccination decisions.\n\n3.4 Statistical Analysis\n\nPrimary Outcome: Knowledge improvement, analyzed via paired t-tests or Mann-Whitney U tests.\n\nSecondary Outcomes: Logistic regression for factors associated with low uptake intentions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged 18 years and older\n* Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.\n* Able to understand and consent to participation in the study.\n\nExclusion Criteria:\n\n* Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.\n* Non-Malaysian'}, 'identificationModule': {'nctId': 'NCT06815250', 'briefTitle': 'Enhancing Maternal Vaccine Knowledge and Uptake: the InTroDuce-Programme Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Effectiveness of the Influenza and Tdap (tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: a Randomised Control Trial Secondary IDs', 'orgStudyIdInfo': {'id': 'InTroDuce-Programme'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard antenatal care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme)', 'interventionNames': ['Behavioral: Influenza and Tdap Vaccination Educational and Learning Module']}], 'interventions': [{'name': 'Influenza and Tdap Vaccination Educational and Learning Module', 'type': 'BEHAVIORAL', 'description': 'Influenza and Tdap learning and educational module delivered via website. The module will cover importance of vaccination for both pregnant women and infant, safety and efficacy of the influenza and TdaP vaccines, timing of vaccination, and addressing common concerns and misconceptions.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43650', 'city': 'Bandar Baru Bangi', 'state': 'Selangor', 'country': 'Malaysia', 'contacts': [{'name': 'Dr Siti Rohani Bt Mohamed Alias, Family Med', 'role': 'CONTACT', 'email': 'ctrohani.alias@moh.gov.my', 'phone': '+60 13-294 5092'}, {'name': 'Dr Siti Rohani Bt Mohamed Alias, Family Med', 'role': 'CONTACT'}], 'facility': 'Klinik Kesihatan Bangi', 'geoPoint': {'lat': 2.9451, 'lon': 101.7735}}, {'zip': '43200', 'city': 'Cheras', 'state': 'Selangor', 'country': 'Malaysia', 'contacts': [{'name': 'Dr Nor Hazlin Bt Talib, Family Med', 'role': 'CONTACT', 'email': 'dr_norhazlin@moh.gov.my', 'phone': '+60192797330'}, {'name': 'Dr Nor Hazlin Bt Talib, Family Med', 'role': 'CONTACT'}], 'facility': 'Klinik Kesihatan Batu 9', 'geoPoint': {'lat': 3.108, 'lon': 101.726}}, {'zip': '43300', 'city': 'Cheras', 'state': 'Selangor', 'country': 'Malaysia', 'contacts': [{'name': 'Dr Nadiah Binti Md Alwi, Family Med', 'role': 'CONTACT', 'email': 'nadiah.alwi@gmail.com', 'phone': '+60173737637'}, {'name': 'Dr Nadiah Binti Md Alwi, Family Med', 'role': 'CONTACT'}], 'facility': 'Klinik Kesihatan Balakong', 'geoPoint': {'lat': 3.108, 'lon': 101.726}}, {'zip': '43000', 'city': 'Kajang', 'state': 'Selangor', 'country': 'Malaysia', 'contacts': [{'name': 'Dr Nur Harnani bt Abdullah, Family Med', 'role': 'CONTACT', 'email': 'nanee801@yahoo.com', 'phone': '+60 17-623 3545'}, {'name': 'Dr Izzah Hazwani binti Dzulkifli, Family Med', 'role': 'CONTACT', 'email': 'dr_izzahhazwani@moh.gov.my', 'phone': '+60 12-392 9950'}, {'name': 'Dr Izzah Hazwani binti Dzulkifli, Family Med', 'role': 'CONTACT'}], 'facility': 'Klinik Kesihatan Kajang', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}], 'centralContacts': [{'name': 'Hung Chiun Lau, Dr Fam Med', 'role': 'CONTACT', 'email': 'hungchiun@upm.edu.my', 'phone': '+60163502549'}, {'name': 'Siew Mooi Ching, Fam Med', 'role': 'CONTACT', 'email': 'sm_ching@upm.edu.my', 'phone': '+60193806652'}], 'overallOfficials': [{'name': 'Hung Chiun Lau, Dr Fam Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Putra Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Lecturer and Family Medicine Specialist', 'investigatorFullName': 'Lau Hung Chiun', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}