NCT03534791

Brief Summary

The intervention will consist of reminders which will be send to the participants randomly via email, with aim to increase the frequency and amount of translated plain language summaries (PLS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

May 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

May 9, 2018

Last Update Submit

July 3, 2019

Conditions

Knowledge Translation

Outcome Measures

Primary Outcomes (1)

  • Number of translated PLSs within the 6 month follow-up

    The number of translated PLSs will be scored in the six months period for a participant

    6 months

Secondary Outcomes (4)

  • Number of translated PLSs after 3 months of follow up

    3 months

  • Time to submitting translation

    6 months

  • Satisfaction with participation in the translation project

    6 months

  • Loss of participants

    6 months

Study Arms (2)

Reminders

EXPERIMENTAL

Reminders customized for each PLS, containing a name of the PLS indicated in the message. If the participants do not translate PLS within 2 months from PLS assignment, we will stop sending them reminders and we will consider them as dropouts.

Other: Reminders

Control group

NO INTERVENTION

Control group will receive no intervention, i.e. standard procedure. Participants in the control group will receive PLSs for translation, in the frequency they indicated, and they will not receive any reminders. They will be assigned new PLSs once they translate the ones that were previously assigned.

Interventions

RemindersOTHER

Personalized email which will aim for reminding of the translator about the PLSs on hold.

Reminders

Eligibility Criteria

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

You may qualify if:

  • adults ≥18 years who volunteered to translate Cochrane PLSs within the Croatian translation project.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Split School of Medicine

Split, Split-Dalmatia County, 21000, Croatia

Location

Related Publications (1)

  • Jakus D, Behmen D, Buljan I, Marusic A, Puljak L. Efficacy of reminders for increasing volunteer engagement in translating Cochrane plain language summaries: a pilot randomised controlled trial. BMJ Evid Based Med. 2021 Apr;26(2):49-50. doi: 10.1136/bmjebm-2020-111378. Epub 2020 Jul 7.

    PMID: 32636205DERIVED

Study Officials

  • Dalibora Behmen, Professor

    Researcher and administrator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Study participants will be blinded to allocation. The author who will communicate with the participants will not be blinded. Other authors and outcome assessors who will analyze data will be blinded to allocation of study participants; anonymized data will be analyzed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All study participants who accept participation in the study will be initially assigned 3 PLSs, and subsequently they will be assigned more PLSs when they translated the previous ones. Intervention group will receive one customized e-mail reminder two weeks after the PLS assignment if they do not translate it within two weeks. Control group will receive no intervention, i.e. standard procedure. Participants in the control group will receive PLSs for translation, in the frequency they indicated, and they will not receive any reminders. They will be assigned new PLSs once they translate the ones that were previously assigned.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 23, 2018

Study Start

May 1, 2018

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Raw data will be posted to the Figshare repository (https://figshare.com/)

Time Frame
Within 12 months from study completion. The data will remain in the public repository indefinitely.
Access Criteria
Open access, publicly available

Locations

CR(1)