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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01266798
Other study ID # REK S-07414b [1.2007.2076]
Secondary ID
Status Completed
Phase N/A
First received December 23, 2010
Last updated December 2, 2014
Start date March 2011
Est. completion date July 2011

Study information

Verified date December 2010
Source Oslo and Akershus University College of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority Norway: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Portal
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. A checklist for critical assessment of health information Access to research databases for health information and an introduction to research methods and principles of science A checklist to the consultation

Locations

Country Name City State
Norway Oslo University College, Faculty of Nursing Oslo

Sponsors (3)

Lead Sponsor Collaborator
Oslo and Akershus University College of Applied Sciences Norwegian Knowledge Centre for the Health Services, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in predictors of search and use of health information 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. Week 3 No
Secondary The ability to find reliable answers to a health question 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. Week 1 No
Secondary Critical appraisal of health information 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. Week 2 No
Secondary Participation (activation) 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. Week 3 No
Secondary Satisfaction with portal 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 Week 3 No
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