- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542201
Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats
September 24, 2018 updated by: University of Split, School of Medicine
Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats: Randomized Controlled Trial
Participants will receive in random order on format of brief description of systematic review summary on health intervention.
One group will receive standard plain language summary, while another will receive Cochrane blog shot, containing only few information about the efficacy of the intervention.
After reading, their task will be to answer several questions about the material they have read.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
238
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
- University of Split School of Medicine
-
-
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients visiting their family doctor, students of biomedical studies.
Exclusion Criteria:
- None
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PLS
Plain abstract about the Cochrane systematic review.
|
Participants will have to read standard textual information about the conducted systematic review (approximately 500 words)
|
|
Experimental: Blogshot
Blogshot presentation of the results of Cochrane systematic review.
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Participants will have to read the blogshot information about the results of the Cochrane systematic review (approximately 100 words)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Understanding
Time Frame: 3 months
|
Number of the correct answers about the content of the summary, which will consist of four multiple choice questions (with four possible answers where only one is correct, for each question) about the text the participants are reading.
Questions will be developed by research team and revised by expert in health communication.
The scale ranges from 0-4, where greater score indicates better understanding of the material.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading experience
Time Frame: 3 months
|
Likert type scale 1-10 (1 indicating low preference for current presentation type, 10 indicating absolute preference for the current presentation type.
|
3 months
|
|
Health numeracy
Time Frame: 3 months
|
5 questions about the numerical tasks placed in medical content, total score is number of correct answers on those questions.
The five questions are part of Numeracy Understanding in Medicine Instrument (Schapira et al, 2012), and we will translate only the questions focusing on Probability section.
Cronbach's alpha in previous research was 0.86 (Schapira et al, 2012).
The questions will be revised by independent translator and back translated to English.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ivan Buljan, MPsy, PhD student
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.
General Publications
- Schapira MM, Walker CM, Cappaert KJ, Ganschow PS, Fletcher KE, McGinley EL, Del Pozo S, Schauer C, Tarima S, Jacobs EA. The numeracy understanding in medicine instrument: a measure of health numeracy developed using item response theory. Med Decis Making. 2012 Nov-Dec;32(6):851-65. doi: 10.1177/0272989X12447239. Epub 2012 May 25.
- Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial. Trials. 2020 May 25;21(1):426. doi: 10.1186/s13063-020-04360-9.
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 (Actual)
April 1, 2018
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
May 17, 2018
First Submitted That Met QC Criteria
May 30, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
September 25, 2018
Last Update Submitted That Met QC Criteria
September 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IP-2014-09-7672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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