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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980107
Other study ID # IP-2014-11-7672
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date December 2016

Study information

Verified date February 2019
Source University Hospital of Split
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice

Intervention

Other:
Infographics
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.
PLS
Text format with simple explanation of the survey topic main findings and is intended for lay audience.

Locations

Country Name City State
Croatia University of Split Split

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of Split University of Liverpool

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Health Numeracy 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)
Primary 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. One month (30 days)
Secondary 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. One month (30 days)
Secondary 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. One month (30 days)
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