NCT03442387

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 29, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

Same day

First QC Date

February 16, 2018

Last Update Submit

February 21, 2018

Conditions

Health Literacy

Outcome Measures

Primary Outcomes (1)

  • Perception of effectiveness

    One item on Likert type scale from 1-10, higher score indicates the higher perceived effectiveness.

    Immediately after reading

Secondary Outcomes (2)

  • Desire to use the described treatment

    Immediately after reading

  • Desire that treatment is prescribed by family doctor

    Immediately after reading

Study Arms (2)

Positive frame

EXPERIMENTAL

The numerical expressions were presented in a positive way: e.g. treatment was successful for 4 out of 10 persons.

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.

Other: Frame of numerical information

Interventions

Frame of numerical informationOTHER

Each group received only one frame of information.

Negative framePositive frame

Eligibility Criteria

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

You may qualify if:

  • First year medical students

You may not qualify if:

  • Those who have failed first year and have to repeat it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 32375659DERIVED

Study Officials

  • Ivan Buljan, MPsy

    University of Split, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

January 29, 2018

Primary Completion

January 29, 2018

Study Completion

January 29, 2018

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Available upon request from principal investigator.

Shared Documents
SAP

Locations

CR(1)