NCT03554252

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 25, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 17, 2018

Last Update Submit

September 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Attitudes towards the appropriateness of this type of presentation of health information

    3 months

  • Health numeracy

    3 months

Study Arms (2)

Frequencies

EXPERIMENTAL
Other: Frequencies

Percentages

EXPERIMENTAL
Other: Percentages

Interventions

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)

Frequencies

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)

Percentages

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants younger than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

Location

Related Publications (2)

  • 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.

    PMID: 22635285BACKGROUND
  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Ivan Buljan, MPsy

    PhD student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 13, 2018

Study Start

April 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations