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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03534791
Other study ID # 2014- 09-7672
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date June 28, 2019

Study information

Verified date July 2019
Source University of Split, School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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. If they still do not translate the PLS, they will receive another customized e-mail reminder after every two weeks until they translate the PLS or until we reach maximum of 4 bi-weekly reminders (at 2 weeks, 4 weeks, 6 weeks and 8 weeks post-assignment) or until participants indicate that they are unable to translate it anymore. Text of the reminder that will be sent to the study participants is available in Supplementary file 1. The reminders will be customized for each PLS, and they will contain 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.

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.

All PLSs will be translated in Memsource, a translation management tool that Cochrane plans to start using since March 2018 for managing translation of summaries. Participants will be followed 6 months from the moment of allocation.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 28, 2019
Est. primary completion date June 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- adults =18 years who volunteered to translate Cochrane PLSs within the Croatian translation project.

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Croatia University of Split School of Medicine Split Split-Dalmatia County

Sponsors (2)

Lead Sponsor Collaborator
University of Split, School of Medicine Croatian Science Foundation

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of translated PLSs after 3 months of follow up The number of translated PLSs will be scored in the three months period for a participant 3 months
Secondary Time to submitting translation The investigators will note the time needed to submit translation 6 months
Secondary Satisfaction with participation in the translation project Likert type scale from 1 to 10 (ranging from 1-completely unsatisfactory to 10-completely satisfactory) 6 months
Secondary Loss of participants Loss of participants from the trial at final follow-up of 6 months, defined as participants' message that they wish to stop translating during the trial period, without later messages during the trial that they wish to engage in translation again. 6 months
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