- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01248520
Influenza and Text Messaging in Pregnancy
12. december 2018 opdateret af: Richard Beigi, University of Pittsburgh
Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake
A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas.
The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates.
Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide.
Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection.
Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost.
Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake.
We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
216
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Magee-Womens Hospital of UPMC
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 50 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Pregnant women less than 28 weeks estimated gestation age
- Between 14-50 years of age
- Willing to provide informed consent and undergo necessary study procedures
Exclusion Criteria:
- Unwillingness or inability to receive text messages
- Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
- Reported history of adverse reaction precluding receipt of the vaccine
- Unwillingness or inability to provide informed consent and comply with study criteria.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: General health information
Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination
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Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
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Aktiv komparator: Influenza and general health information
Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts
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Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.
Tidsramme: at participant post-partum visit
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To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.
We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.
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at participant post-partum visit
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.
Tidsramme: at participant post-partum visit
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To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.
We hypothesize that women receiving text messages will be more likely than controls to have accurate knowledge about pregnant women's increased susceptibility to influenza and about the vaccine's safety and efficacy in pregnancy.
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at participant post-partum visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michelle Moniz, MD, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2010
Primær færdiggørelse (Faktiske)
1. maj 2012
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
23. november 2010
Først indsendt, der opfyldte QC-kriterier
23. november 2010
Først opslået (Skøn)
25. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO09100504
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
Kliniske forsøg med general health information
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H. Lee Moffitt Cancer Center and Research InstitutePatient-Centered Outcomes Research InstituteAfsluttet
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Brigham and Women's HospitalAgency for Healthcare Research and Quality (AHRQ)RekrutteringGastrointestinale sygdomme | Hjertefejl | Infektioner | Urologiske sygdomme | Stød | Hæmatologiske sygdomme | Kritisk sygdom | Reumatiske sygdomme | Astma | Nyresvigt | Neurologisk lidelse | KOL eksacerbation | Hjertebegivenhed | Onkologisk problem | Arytmi | NyresygdomForenede Stater
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Dana-Farber Cancer InstituteChildren's Cancer Research FundAfsluttet
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University of PennsylvaniaNational Institute on Aging (NIA)Rekruttering
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NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetForhøjet blodtryk | MedicinadhærensForenede Stater
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North Bronx Healthcare NetworkTrukket tilbageForhøjet blodtryk | Diabetes | HIVForenede Stater
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ETR AssociatesNational Institute on Minority Health and Health Disparities (NIMHD); Portland... og andre samarbejdspartnereAfsluttetHIV/AIDS | Sundhedsviden, holdninger, praksis | STIForenede Stater
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Ohio State UniversityRekruttering
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Vidya RamanAfsluttet
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Jouf UniversityAfsluttetEffekt af sundhedsinformationspakkeprogram på viden og overholdelse blandt gravide kvinder med anæmiAnæmi | Gravid kvinde | VidenSaudi Arabien