Health Knowledge, Attitudes, PracticeNCT03554252
Comparison of Different Frames of Numerical Information in Cochrane Plain Language Summaries
A study testing Frequencies and Percentages in people with Health Knowledge, Attitudes, Practice, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Frequencies and Percentages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2018to 1 Aug 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are visiting their family doctor, and are at least 18 old. Students of biomedical studies at University of Split School of Medicine, who are at least 18 years old.
Who cannot join
- Participants younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Frames of Numerical Information in Cochrane Plain Language: Randomized Controlled Trial
Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another format the frames will be reversed (results will be presented as percentages and side effects as frequencies). After reading, participants will be asked several questions about the content of the summary and its conclusions.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Frequencies, Percentages
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrequenciesOther
Results are presented as natural frequencies (e.g. the drug was effective for 1 out of 10 people) while side effects are presented as percentages (e.g. 40% participants experienced severe side effects)
PercentagesOther
Results are presented as percentages (e.g. the drug was effective for 10% of people) while side effects are presented as natural frequencies (e.g. 4 out of 10 participants experienced severe side effects)
| Study group | Role | What they receive |
|---|---|---|
| Frequencies | Experimental | Not described Receives: Other: Frequencies |
| Percentages | Experimental | Not described Receives: Other: Percentages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding
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.
Measured: 3 months
Secondary outcomes (2)
Attitudes towards the appropriateness of this type of presentation of health information
Likert type scale from 1-10 (1 indicating low appropriateness and 10 would be completely appropriate presentation)
Measured: 3 months
Health numeracy
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. The scale range is from 0-5, where higher score indicates higher numeracy levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Buljan, MPsy, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554252
- Sponsor's protocol ID
- 214-09-7672
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22635285Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4.
PubMed 32375659
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Frames of Numerical Information in Cochrane Plain Language: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03554252
- Acronym / sponsor ID
- 214-09-7672
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- 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.
Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another format the frames will be reversed (results will be presented as percentages and side effects as frequencies). After reading, participants will be asked several questions about the content of the summary and its conclusions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequencies | Experimental | Other: Frequencies |
| Percentages | Experimental | Other: Percentages |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are visiting their family doctor, and are at least 18 old. Students of biomedical studies at University of Split School of Medicine, who are at least 18 years old.
Key exclusion criteria (1 listed)
- Participants younger than 18 years.
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 |
|---|---|---|
| FrequenciesResults are presented as natural frequencies (e.g. the drug was effective for 1 out of 10 people) while side effects are presented as percentages (e.g. 40% participants experienced severe side effects) | Other | Frequencies |
| PercentagesResults are presented as percentages (e.g. the drug was effective for 10% of people) while side effects are presented as natural frequencies (e.g. 4 out of 10 participants experienced severe side effects) | Other | Percentages |
Primary outcome
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.
2 secondary outcomes
Attitudes towards the appropriateness of this type of presentation of health information
Time frame: 3 months
Health numeracy
Time frame: 3 months
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 25 Sep 2018.
- Background: PubMed 22635285Schapira 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.
- Derived from this study: PubMed 32375659Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4.
- Individual participant dataSharing planned: No
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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, MPsy principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequencies and Percentages in people with Health Knowledge, Attitudes, Practice, run by University of Split, School of Medicine 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 25 Sep 2018. 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?
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?
Understanding (time frame: 3 months). 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 NCT03554252, which also lists 2 linked publications.
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 25 Sep 2018.