Health LiteracyNCT03442387
Framing of Numerical Information in Cochrane Summaries
A study testing Frame of numerical information in people with Health Literacy, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- Frame of numerical information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCroatia
- Study dates
- 29 Jan 2018to 29 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First year medical students
Who cannot join
- Those who have failed first year and have to repeat it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Framing of Numerical Information in Cochrane Summaries: a Randomized Controlled Trial
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.
Read the detailed description
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.
- Conditions
- Health Literacy
- Being tested
- Frame of numerical information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frame of numerical informationOther
Each group received only one frame of information.
| Study group | Role | What they receive |
|---|---|---|
| Positive frame | Experimental | The numerical expressions were presented in a positive way: e.g. treatment was successful for 4 out of 10 persons. Receives: Other: Frame of numerical information |
| Negative frame | Experimental | The numerical expressions were presented in a negative way: e.g. treatment was unsuccessful for 6 out of 10 persons. Receives: Other: Frame of numerical information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of effectiveness
One item on Likert type scale from 1-10, higher score indicates the higher perceived effectiveness.
Measured: Immediately after reading
Secondary outcomes (2)
Desire to use the described treatment
One item on Likert type scale from 1-10, higher score indicates the greater desire to use the described treatment.
Measured: Immediately after reading
Desire that treatment is prescribed by family doctor
One item on Likert type scale from 1-10. Higher score indicates the greater desire that treatment is prescribed by family doctor.
Measured: Immediately after reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start29 Jan 2018
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Buljan, University of Split, School of Medicine
- Investigators
- Ivan Buljan, MPsy, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442387
- Sponsor's protocol ID
- Grant No. IP-2014-09-7672
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request from principal investigator.
Publications
Buljan 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 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Framing of Numerical Information in Cochrane Summaries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03442387
- Acronym / sponsor ID
- Grant No. IP-2014-09-7672
- Conditions
- Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 22 Feb 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.
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.
Detailed description
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive frame | Experimental | Other: Frame of numerical informationThe numerical expressions were presented in a positive way: e.g. treatment was successful for 4 out of 10 persons. |
| Negative frame | Experimental | Other: Frame of numerical informationThe numerical expressions were presented in a negative way: e.g. treatment was unsuccessful for 6 out of 10 persons. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First year medical students
Key exclusion criteria (1 listed)
- Those who have failed first year and have to repeat it.
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 |
|---|---|---|
| Frame of numerical informationEach group received only one frame of information. | Other | Negative frame, Positive frame |
Primary outcome
Perception of effectiveness
Time frame: Immediately after reading
One item on Likert type scale from 1-10, higher score indicates the higher perceived effectiveness.
2 secondary outcomes
Desire to use the described treatment
Time frame: Immediately after reading
Desire that treatment is prescribed by family doctor
Time frame: Immediately after reading
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 26 Feb 2018.
- 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: Yes. Available upon request from principal investigator.
Related trials for Health Literacy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
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
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frame of numerical information in people with Health Literacy, 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 26 Feb 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?
Perception of effectiveness (time frame: Immediately after reading). 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 NCT03442387, 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 26 Feb 2018.