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Brief Reminders as Intervention for Greater Engagement of Cochrane Translators

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ClinicalTrials.gov Identifier: NCT03534791
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Croatian Science Foundation
Information provided by (Responsible Party):
Dalibora Behmen, University of Split, School of Medicine

Tracking Information
First Submitted Date  ICMJE May 9, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)		 Number of translated PLSs within the 6 month follow-up [ Time Frame: 6 months ]
The number of translated PLSs will be scored in the six months period for a participant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • Number of translated PLSs after 3 months of follow up [ Time Frame: 3 months ]
    The number of translated PLSs will be scored in the three months period for a participant
  • Time to submitting translation [ Time Frame: 6 months ]
    The investigators will note the time needed to submit translation
  • Satisfaction with participation in the translation project [ Time Frame: 6 months ]
    Likert type scale from 1 to 10 (ranging from 1-completely unsatisfactory to 10-completely satisfactory)
  • Loss of participants [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Reminders as Intervention for Greater Engagement of Cochrane Translators
Official Title  ICMJE Interventions for Increasing Volunteer Engagement in Knowledge Translation Activity of Translating Cochrane Plain Language Summaries: a Randomized Controlled Trial
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).
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Knowledge Translation
Intervention  ICMJE Other: Reminders
Personalized email which will aim for reminding of the translator about the PLSs on hold.
Study Arms  ICMJE
  • Experimental: Reminders
    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.
    Intervention: Other: Reminders
  • No Intervention: Control group
    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.
Publications * Jakus D, Behmen D, Buljan I, Marušić 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. 2020 Jul 7. pii: bmjebm-2020-111378. doi: 10.1136/bmjebm-2020-111378. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)		 80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03534791
Other Study ID Numbers  ICMJE 2014- 09-7672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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
Responsible Party Dalibora Behmen, University of Split, School of Medicine
Study Sponsor  ICMJE University of Split, School of Medicine
Collaborators  ICMJE Croatian Science Foundation
Investigators  ICMJE
Principal Investigator: Dalibora Behmen, Professor Researcher and administrator
PRS Account University of Split, School of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP