- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oslo, Norway, 0130
- Oslo University College, Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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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No Intervention: Treatment as usal
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in predictors of search and use of health information
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The ability to find reliable answers to a health question
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sølvi Helseth, Professor, Oslo University College
- Study Director: Arild Bjørndal, Professor, Oslo University
- Principal Investigator: Astrid Austvoll-Dahlgren, MA, Oslo University College
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REK S-07414b [1.2007.2076]
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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