Knowledge TranslationNCT03534791
Brief Reminders as Intervention for Greater Engagement of Cochrane Translators
A study testing Reminders in people with Knowledge Translation, run by University of Split, School of Medicine at 1 site in Croatia.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge Translation
- What is being tested?
- Reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 May 2018to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults ≥18 years who volunteered to translate Cochrane PLSs within the Croatian translation project.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University of Split School of Medicine
Split, Split-Dalmatia County, 21000
About this study
Official title: Interventions for Increasing Volunteer Engagement in Knowledge Translation Activity of Translating Cochrane Plain Language Summaries: a Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Knowledge Translation
- Being tested
- Reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemindersOther
Personalized email which will aim for reminding of the translator about the PLSs on hold.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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
Measured: 3 months
Time to submitting translation
The investigators will note the time needed to submit translation
Measured: 6 months
Satisfaction with participation in the translation project
Likert type scale from 1 to 10 (ranging from 1-completely unsatisfactory to 10-completely satisfactory)
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 May 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge TranslationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Principal investigator, Dalibora Behmen, University of Split, School of Medicine
- Investigators
- Dalibora Behmen, Professor, Principal investigator, Researcher and administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534791
- Sponsor's protocol ID
- 2014- 09-7672
- Status last verified
- Jul 2019
- First submitted
- 9 May 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be posted to the Figshare repository (https://figshare.com/)
Publications
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.
PubMed 32636205
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Increasing Volunteer Engagement in Knowledge Translation Activity of Translating Cochrane Plain Language Summaries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03534791
- Acronym / sponsor ID
- 2014- 09-7672
- Conditions
- Knowledge Translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- Croatian Science Foundation
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reminders | Experimental | Other: RemindersReminders 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults ≥18 years who volunteered to translate Cochrane PLSs within the Croatian translation project.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemindersPersonalized email which will aim for reminding of the translator about the PLSs on hold. | Other | Reminders |
Primary outcome
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
4 secondary outcomes
Number of translated PLSs after 3 months of follow up
Time frame: 3 months
Time to submitting translation
Time frame: 6 months
Satisfaction with participation in the translation project
Time frame: 6 months
Loss of participants
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 32636205Jakus 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.
- Individual participant dataSharing planned: Yes. Raw data will be posted to the Figshare repository (https://figshare.com/)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalibora Behmen, Professor principal investigator
Researcher and administrator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders in people with Knowledge Translation, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of translated PLSs within the 6 month follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.