- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Oslo, Norwegen, 0130
- Oslo University College, Faculty of Nursing
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Kein Eingriff: Treatment as usal
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Changes in predictors of search and use of health information
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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The ability to find reliable answers to a health question
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Sølvi Helseth, Professor, Oslo University College
- Studienleiter: Arild Bjørndal, Professor, Oslo University
- Hauptermittler: Astrid Austvoll-Dahlgren, MA, Oslo University College
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- REK S-07414b [1.2007.2076]
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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