- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oslo, Norvegia, 0130
- Oslo University College, Faculty of Nursing
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Treatment as usal
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in predictors of search and use of health information
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The ability to find reliable answers to a health question
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Sølvi Helseth, Professor, Oslo University College
- Direttore dello studio: Arild Bjørndal, Professor, Oslo University
- Investigatore principale: Astrid Austvoll-Dahlgren, MA, Oslo University College
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- REK S-07414b [1.2007.2076]
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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