- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02420964
Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications
The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.
Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.
Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.
Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.
Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Design:
The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.
Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.
Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.
Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.
Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.
Methods:
- A responsible clinician who has acquainted himself/herself with the research protocol will explain the study to each patient. Patients who agree to participate will sign a form documenting informed consent. The patient will then be handed an envelope that determines whether they will receive web-based teaching or one-on-one teaching.
- The patients receiving web-based teaching will be taken to a private room to watch a video on injectable medication use. The amount of time required to view the video will be recorded. The video can be paused, rewound and watched as many times as the patient desires.
- The patients randomized to one-on-one teaching will be taken to a separate room where they will be taught injectable medication use by one of two training healthcare providers with experience teaching injectable medications. The time spent in the teaching session will be recorded.
- After the teaching session, each patient in the study will complete a multiple choice post-test regarding their knowledge of injectable medication use. They will also complete a satisfaction survey which will use a Likert scale to assess the patients' responses. The instructors teaching the one-on-one sessions will not have access to the post-test.
Statistics:
The categorical variables will be summarized with frequencies and percentages while the continuous variables will be evaluated with means and standard deviations. A difference in proportion will be tested based on the data collected between the web-based group and didactic group. Non-inferiority testing will be conducted based on these differences with a 5% significance level. Data analysis will be conducted using SAS statistical software (9.2,Cary,NC,USA) .
Sample Size Estimate:
To predict that the web-based testing group is not inferior to the Didactic testing group about 40 people in each group would be needed to achieve 80% power with a 5% significance level. The sample size needed was calculated using the Z-test. Here it is assumed that the didactic group would get 80% of their answers correct and the web-based group would actually have 90% of their answers correct.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28204
- Carolinas Medical Center - Women's Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patient undergoing ART Therapy and ovulation induction via gonadotropins injection.
Exclusion Criteria:
- Any patient with prior history of IVF injectable use will be excluded from the study.
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 |
|---|---|
|
Outro: Nurse instruction
Traditional injection teaching method.
No video instruction
|
Nurse directed instruction
|
|
Outro: Video instruction
Video instruction that can be paused/repeated by subject
|
Patient Directed Video Instruction
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tthe level of knowledge after the intervention measured by a multiple choice post-test
Prazo: approximately 1 hour
|
multiple choice post-test regarding their knowledge of injectable medication use
|
approximately 1 hour
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Satisfaction with education measured by the Likert scale survey
Prazo: post intervention
|
post intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michelle Matthews, MD, Wake Forest University Health Sciences
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- 06-12-10E
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 .