Health Knowledge, Attitudes, PracticeNCT02980107
Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary
A study testing Infographics and PLS in people with Health Knowledge, Attitudes, Practice, run by University Hospital of Split at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Infographics and PLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteCroatia
- Study dates
- Nov 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible participants will be members of RODA and Association for Patients' Rights (women) .
Who cannot join
- Male members of RODA and Association for Patient's Rights
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Infographics, PLS
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfographicsOther
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.
PLSOther
Text format with simple explanation of the survey topic main findings and is intended for lay audience.
| Study group | Role | What they receive |
|---|---|---|
| PLS | Active comparator | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Receives: Other: PLS |
| Infographics | Experimental | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Receives: Other: Infographics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of the Summary Content
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.
Measured: One month (30 days)
Secondary outcomes (2)
Reading Experience
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.
Measured: One month (30 days)
User Friendliness
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.
Measured: One month (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Principal investigator, Ivan Buljan, University Hospital of Split
- Investigators
- Ivan Buljan, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980107
- Sponsor's protocol ID
- IP-2014-11-7672
- Status last verified
- Feb 2019
- First submitted
- 25 Nov 2016
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.
PubMed 23433635
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary
- ClinicalTrials.gov ID
- NCT02980107
- Acronym / sponsor ID
- IP-2014-11-7672
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLS | Active comparator | Other: PLSThe control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. |
| Infographics | Experimental | Other: InfographicsInfographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be members of RODA and Association for Patients' Rights (women) .
Key exclusion criteria (1 listed)
- Male members of RODA and Association for Patient's Rights
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 |
|---|---|---|
| InfographicsCochrane 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. | Other | Infographics |
| PLSText format with simple explanation of the survey topic main findings and is intended for lay audience. | Other | PLS |
Primary outcome
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.
2 secondary outcomes
Reading Experience
Time frame: One month (30 days)
User Friendliness
Time frame: One month (30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23433635Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.
- Web page where new formats for presentation of Cochrane systematic reviews can be found.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Ivan Buljan principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infographics and PLS in people with Health Knowledge, Attitudes, Practice, run by University Hospital of Split at 1 site in Croatia.
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 1 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 Jun 2019. 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 Croatia. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Understanding of the Summary Content (time frame: One month (30 days)). 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 NCT02980107, 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 Jun 2019.