- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03225885
Counseling for Prematurity Using a Multimedia Education Tool
Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent Education Tool
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Approximately 500,000 infants are born prematurely in the United States every year. Premature birth prior to 27 weeks gestation currently accounts for approximately 40% of infant mortality within the United States. When compared to full term infants, premature infants have a higher risk of physical or cognitive impairment and prematurity care accounts for over 26 billion dollars annually. Parents of premature infants are placed under significant emotional, financial, and personal stress. However, parental education about prematurity is often not evidenced based, varies significantly between OB and Neonatology providers, and lacks educational aids to help parents comprehend the information provided.
Several medical societies (American Academy of Pediatrics (AAP), American Congress of Obstetrics and Gynecology (ACOG), National Institute of Child Health and Human Development (NICHD)) and parental advocates have voiced concern that the current practice is sub-optimal. Several studies have looked at this challenging situation from the family's perspective and have shown that parents find this counseling to be helpful but rarely reassuring and often stressful. Cognitive science research has recommended the use of multimedia information to simultaneously use both text and visual cognitive channels to improve information uptake and retention. Policy statements from the AAP, ACOG, and NICHD have all emphasized the importance of improving the prenatal counseling process to give our parents the most information possible so that they can make the best choices possible for their vulnerable infant.
Potential study participants will be identified after hospitalization at Froedtert Hospital for premature labor. As per current clinical practice all mothers and their support person will have a neonatology consult requested by the obstetrician. These potential participants will be screened for eligibility in the study. Mothers and their support person will then be consented for participation and will be randomized to receive either verbal counseling with printed gestational age handout or verbal counseling with the multimedia information regarding prematurity. Participation of the pregnant woman's support person will be allowed by not required. If both mother and support person consent to participate, the support person will be will be assigned the same group as the mother. Participants will take a baseline STAI (State-Trait Anxiety Inventory) at time of randomization. After prenatal counseling has been completed by a neonatal provider (neonatology attending or fellow) the participants will be provided the validated questionnaire (previously developed) to assess their knowledge of prematurity based on the AAP recommended information for parents anticipating a premature birth. Participants will also retake the STAI.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- English speaking
- Admitted to Labor and Delivery unit due to concerns for premature delivery, gestational age of fetus between 22 weeks 0 days and 33 weeks 6 days
Exclusion Criteria:
- known significant genetic abnormality or congenital anomaly that would effect survival or counseling that parents receive
- participants will be excluded from analysis if delivery occurs prior to completion of questionnaires as other sources of information become available after birth
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Printed Handout
Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as a printed gestational age specific handout about prematurity.
|
Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.
|
Experimental: Multimedia Information
Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as have bedside access to iPad multimedia information regarding prematurity.
|
Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Overall knowledge of prematurity
Prazo: within 24 hours of verbal counseling session
|
Average of overall knowledge score
|
within 24 hours of verbal counseling session
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Gestational age sub-group knowledge scores
Prazo: within 24 hours of verbal counseling session
|
Comparison of average overall knowledge scores within gestational age groups 22-24 weeks and 25-29 weeks and 30-33 weeks gestation.
|
within 24 hours of verbal counseling session
|
Sub-domain knowledge scores
Prazo: within 24 hours of verbal counseling session
|
Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments
|
within 24 hours of verbal counseling session
|
Anxiety
Prazo: within 24 hours of verbal counseling
|
Comparison of change in participant anxiety as assessed by STAI
|
within 24 hours of verbal counseling
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mir A Basir, MD, Medical College of Wisconsin
Publicações e links úteis
Publicações Gerais
- Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
- Cummings J; COMMITTEE ON FETUS AND NEWBORN. Antenatal Counseling Regarding Resuscitation and Intensive Care Before 25 Weeks of Gestation. Pediatrics. 2015 Sep;136(3):588-95. doi: 10.1542/peds.2015-2336.
- Raju TNK, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014 May;123(5):1083-1096. doi: 10.1097/AOG.0000000000000243.
- Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRO00028712
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .