- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980107
Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary
February 18, 2019 updated by: Ivan Buljan, University Hospital of Split
The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS format, in presenting information, in terms of understanding and remembering research results by consumers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators will conduct a randomized controlled trial (RCT) with two different formats of the same systematic review summary (Infographics, PLS).
The content of these two formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language and plain language only.
The interventions will be delivered online in November 2016, with members of the consumers' groups for pregnancy and parenting - RODA ("Roditelji u akciji", engl."Parents in action"), which gathers different types of consumers: pregnant women, young mothers and parenting and pregnancy advisors; and the members of the Association for Patients' Rights.
The trial will be voluntary and anonymous.
The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.
Study Type
Interventional
Enrollment (Actual)
212
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
-
-
-
Split, Croatia, 21000
- University of Split
-
-
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
Female
Description
Inclusion Criteria:
- Eligible participants will be members of RODA and Association for Patients' Rights (women) .
Exclusion Criteria:
- Male members of RODA and Association for Patient's Rights
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PLS
The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.
|
Text format with simple explanation of the survey topic main findings and is intended for lay audience.
|
|
Experimental: Infographics
Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.
|
Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Understanding of the Summary Content
Time Frame: One month (30 days)
|
The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review.
There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10).
Higher scores would represent greater understanding of the content.
|
One month (30 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading Experience
Time Frame: One month (30 days)
|
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 5, maximum 50).
Greater scores indicate more positive reading experience.
|
One month (30 days)
|
|
User Friendliness
Time Frame: One month (30 days)
|
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 5, maximum 50).
Higher scores indicate greater perception of the summary format as more user friendly.
|
One month (30 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Numeracy
Time Frame: One month (30 days)
|
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 month (30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ivan Buljan, Researcher
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
November 25, 2016
First Submitted That Met QC Criteria
December 1, 2016
First Posted (Estimate)
December 2, 2016
Study Record Updates
Last Update Posted (Actual)
June 3, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IP-2014-11-7672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.
Clinical Trials on Health Knowledge, Attitudes, Practice
-
Universiti Teknologi MaraUniversiti Putra Malaysia; Ministry of Health, Malaysia; Institute for Health... and other collaboratorsRecruitingHealth Attitude | Health Behavior | Knowledge, Attitudes, Practice | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Behavior, Health | Attitude to Health | Preparedness | OutbreaksMalaysia
-
Amref Health AfricaRecruitingHealth Knowledge, Attitudes, PracticeKenya
-
Nigde Omer Halisdemir UniversityGazi University; Ankara Yildirim Beyazıt UniversityRecruitingHealth Knowledge, Attitudes, PracticeTurkey
-
Bournemouth UniversityUniversity College, London; University of Leeds; University of SouthamptonCompletedHealth Knowledge, Attitudes, PracticeUnited Kingdom
-
Galderma R&DCompletedHealth Knowledge, Attitudes, PracticeFrance, Germany, Spain, United Kingdom
-
Virginia Commonwealth UniversityCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Chang Gung Memorial HospitalCompletedHealth Knowledge, Attitudes, PracticeTaiwan
-
Goethe UniversityUnknownHealth Knowledge, Attitudes, PracticeGermany
-
Continuity Research NetworkCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Knowledge, Attitudes, PracticeTurkey
Clinical Trials on PLS
-
University of Split, School of MedicineUniversity Hospital of SplitEnrolling by invitationNon-Metastatic Breast CancerCroatia
-
University of Split, School of MedicineCompletedHealth Knowledge, Attitudes, PracticeCroatia
-
University Hospital of SplitUniversity of LiverpoolCompletedHealth Knowledge, Attitudes, PracticeCroatia
-
Interventional Spine, Inc.Withdrawn
-
Taipei Medical University HospitalCompleted
-
University Hospital of SplitCroatian Science FoundationCompletedUnderstanding Cochrane Systematic ReviewsCroatia
-
University of LimerickCompleted
-
Nova Southeastern UniversityRecruitingAmyotrophic Lateral Sclerosis (ALS) | Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Primary Lateral Sclerosis (PLS)United States