- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01266798
Effects of a Patient Directed Web-portal to Improve Health Literacy Skills (PREP)
Access to the best available evidence, and the ability to obtain and understand such information is seen as necessary to protect the public's interests and critical to empowerment, but is also a precondition for participation in the decision making.
A web portal serving as a generic (non disease- specific) tailored tool was developed in the conceptual framework of shared decision making and evidence based practice to improve the lay- public's critical and social literacy skills and activation. A randomized controlled parallel trial using a simple randomization procedure will be conducted, including 200 parents of children <4 with internet access. Parents will be allocated to receive either the portal or no intervention. Primary and secondary outcomes include: the ability to find research based information, critical appraisal skills, perceived behavioural control, attitudes and perceived pressure associated with searching for information, and participation.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Oslo, Noruega, 0130
- Oslo University College, Faculty of Nursing
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Parents of children age <4 will be recruited with access to internet.
Exclusion Criteria:
- Participants will be excluded if one other in the household already participates in the study (due to spill-over effect) and if they do not have children <4.
- Since the recruitment will be done online, there is no need to screen for access to internet.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Portal arm
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The portal was tailored to improve the lay public's' "healthy skepticism", or in other words, critical and social literacy skills to assist patients in the decision-making process and for improving access to health information and participation. Illustrated by typical examples which can be found in the news and through patient stories, the portal provides an introduction to research methods, the underlying principles of science and critical assessment tools appropriate for a lay public.
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Sem intervenção: Treatment as usal
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes in predictors of search and use of health information
Prazo: Week 3
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Based on the theory of planned behavioral manual a questionnaire has been developed and validated in order to explore what predictors (efficacy, attitudes and perceived pressure) to search and use of health infomration.
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Week 3
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The ability to find reliable answers to a health question
Prazo: Week 1
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Participants will be asked to formulate a (health) question and to find information that can answer this question.
The participants will be asked to copy and paste the internet link to the information they found.The outcome will be evaluated pragmatically by categorizing the information as based on: 1. research or 2. expert advice/ other.
The information will be categorized blindly by two independent researchers.
The direction of effect is expected to be positive, in that more participants will find research based information than those in the control group.
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Week 1
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Critical appraisal of health information
Prazo: Week 2
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Participants will be asked to rate a piece of health information about childhood vaccination using DISCERNs item number 16. DISCERN is an instrument designed to judge the quality of written information about treatment choices.
The mean value rating of the information will be measured against a "standard" rating made by experts on the same information.
The direction of effect is predicted to be positive, in that the mean overall score of the intervention group will be closer to the standard than the control group.
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Week 2
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Participation (activation)
Prazo: Week 3
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The patient activation measure (PAM) has been developed to measure activation.
The instrument includes 4 domains; believing the patient role is important, having confidence and knowledge necessary to taking action, actually taking action to improve one's health, and staying the course under stress.
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Week 3
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Satisfaction with portal
Prazo: Week 3
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We will also ask participants to comment on satisfaction with the portal after the other data collection has been submitted.
This will be done based on the Honeycomb criteria which were also used in the qualitative evaluation.
The honeycomb model is a well-renowned and much used instrument to measure user experience
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Week 3
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Sølvi Helseth, Professor, Oslo University College
- Diretor de estudo: Arild Bjørndal, Professor, Oslo university
- Investigador principal: Astrid Austvoll-Dahlgren, MA, Oslo University College
Publicações e links úteis
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- REK S-07414b [1.2007.2076]
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 .
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