- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02918656
Presenting Summary Information From Cochrane Systematic Reviews
June 1, 2019 updated by: Ivan Buljan, University Hospital of Split
Presenting Summary Information From Cochrane Systematic Reviews: Randomized Controlled Trial of Infographics Presentation vs. Standard Word Summaries
The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum).
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators will conduct a randomized control trial (RCT) with three different formats of the same systematic review summary (infographics, PLS and scientific summary).
The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation, plain language, and scientific language.
The trial will be performed at the beginning of the 2016/2017 academic year, with first year university students as participants.
The trial will be voluntary and anonymous.
The survey will consist of 4 parts: 1) demographic data, 2) one format of the summary (randomly assigned), 3) comprehension test of the information given in the summary, 4) accessibility of information and overall satisfaction with the given summary assessed by survey and 5) health numeracy test.
All materials will be in Croatian.
The materials used in this research will be assessed by experts in order to confirm face validity of developed questions.
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Split, Croatia, 21000
- School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligible participants will be first-year university students without experience with Cochrane review summaries, because prior familiarization with Cochrane summaries could make information uptake easier by those participants.
Exclusion criteria:
- Participants who give the positive answer to the survey question about familiarity with the Cochrane will be excluded from the study analysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infographics
Infographic presentation of health information
|
The students in this group will read Cochrane systematic review summary in infographics format. Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs. |
Active Comparator: Plain Language Summary
PLS presentation of health information
|
The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience.
|
Active Comparator: Scientific abstract
Scientific abstract presentation of health information
|
The students in scientific abstract group will read the the text written for the academic population and practitioners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding
Time Frame: One-hour after the intervention
|
The primary outcome of the study is the score on a understanding test with ten questions about information contained in all three forms of presentation, titled as "Understanding information about external cephalic version for breech presentation before term" (Hutton et al, 2015).
The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review.
Each correctly answered question will be awarded one point, with a maximum of 10 points.
The scale was specifically designed for this research, they ask about the information contained in all three abstract format and all questions are open-ended.
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One-hour after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading Experience
Time Frame: One hour after the intervention
|
This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree.
The total score is the sum of scores on all five answers (minimum score was 10 and maximum 50).
Higher scores indicate greater reading experience, which means that a person was assessed that type of reading material as more enjoyable.
So, higher scores are associated with more positive reading experience.
|
One hour after the intervention
|
Accessibility of Relevant Information
Time Frame: One hour after the intervention
|
This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree.
The total score is the sum of scores on all the answers (minimum score was 5, maximum 50).
The higher score indicated that the reading material was perceived as more user friendly and that it was easier to find the desired information.
|
One hour after the intervention
|
Health Numeracy Score
Time Frame: One hour after the intervention
|
This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension.
For each correct answer, the participants receive one point and the total score is the sum of all correct answers.
|
One hour after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Marušić, MD, PhD, Professor at Medical School of Split
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
September 27, 2016
First Submitted That Met QC Criteria
September 27, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
June 1, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IP-2014-09-7672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be collected electronically, using the SurveyMonkey platform.
The data will be fully anonymous and will be kept on a secure server of the School of Medicine.
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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