Health BehaviorPREPNCT01266798
Effects of a Patient Directed Web-portal to Improve Health Literacy Skills
A study testing Portal in people with Health Behavior, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Portal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of children age <4 will be recruited with access to internet.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health Behavior
- Being tested
- Portal
- Keywords
- Health literacy, participation
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PortalBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Portal arm | Experimental | Not described Receives: Behavioral: Portal |
| Treatment as usal | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 3
Secondary outcomes (4)
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.
Measured: Week 1
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.
Measured: Week 2
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.
Measured: Week 3
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
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Knowledge Centre for the Health Services
- Responsible party
- Sponsor
- Investigators
- Sølvi Helseth, Professor, Study director, Oslo University CollegeArild Bjørndal, Professor, Study director, Oslo universityAstrid Austvoll-Dahlgren, MA, Principal investigator, Oslo University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266798
- Sponsor's protocol ID
- REK S-07414b [1.2007.2076]
- Acronym
- PREP
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
Publications
Austvoll-Dahlgren A, Bjorndal A, Odgaard-Jensen J, Helseth S. Evaluation of a web portal for improving public access to evidence-based health information and health literacy skills: a pragmatic trial. PLoS One. 2012;7(5):e37715. doi: 10.1371/journal.pone.0037715. Epub 2012 May 31.
PubMed 22701531
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Patient Directed Web-portal to Improve Health Literacy Skills
- ClinicalTrials.gov ID
- NCT01266798
- Acronym / sponsor ID
- PREP / REK S-07414b [1.2007.2076]
- Conditions
- Health Behavior
- Keywords
- Health literacy, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Knowledge Centre for the Health Services
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portal arm | Experimental | Behavioral: Portal |
| Treatment as usal | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of children age <4 will be recruited with access to internet.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PortalThe 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. 1. A checklist for critical assessment of health information 2. Access to research databases for health information and an introduction to research methods and principles of science 3. A checklist to the consultation | Behavioural | Portal arm |
Primary outcome
Changes in predictors of search and use of health information
Time frame: Week 3
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.
4 secondary outcomes
The ability to find reliable answers to a health question
Time frame: Week 1
Critical appraisal of health information
Time frame: Week 2
Participation (activation)
Time frame: Week 3
Satisfaction with portal
Time frame: Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 22701531Austvoll-Dahlgren A, Bjorndal A, Odgaard-Jensen J, Helseth S. Evaluation of a web portal for improving public access to evidence-based health information and health literacy skills: a pragmatic trial. PLoS One. 2012;7(5):e37715. doi: 10.1371/journal.pone.0037715. Epub 2012 May 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sølvi Helseth, Professor study director
Oslo University College
Arild Bjørndal, Professor study director
Oslo university
Astrid Austvoll-Dahlgren, MA principal investigator
Oslo University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portal in people with Health Behavior, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in predictors of search and use of health information (time frame: Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.