Nudging in clinical trial registration

Last registered on October 13, 2023

Pre-Trial

Trial Information

General Information

Title
Nudging in clinical trial registration
RCT ID
AEARCTR-0011161
Initial registration date
May 25, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 06, 2023, 9:15 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
October 13, 2023, 4:39 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
BfArM Federal Institute for Drugs and Medical Device

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2023-06-05
End date
2023-08-22
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The aim of this field experiment is to test whether study registrants in the German Clinical Trials Register can be nudged to complete their registration.
The greatest effort for the study registrant, but also for the registry staff, arises during the initial application for registration. Afterwards, usually only a few queries have to be processed in order to complete the registration in the registry.
In this experiment, these entries are identified and randomised into 3 groups. 2 groups receive emails with a selected nudges. 1 group serves as a control.
The primary objective is whether the study will be registered within 6 weeks of the nudge.
Secondary objectives are
- Feedback from the study managers (Mail or Phone)
- Changes to the study entry
- Deletion of the study entry
- Login from the study managers
External Link(s)

Registration Citation

Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. October 13. https://doi.org/10.1257/rct.11161-3.1
Experimental Details

Interventions

Intervention(s)
E-Mails with selected Nudges
Intervention Start Date
2023-06-12
Intervention End Date
2023-06-13

Primary Outcomes

Primary Outcomes (end points)
Number of study entries registered by end of intervention
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
- feedback from the study managers
- Changes to the study entry
- Deletion of the study entry
- Login form the study managers
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Study entries will be randomly assigned to one of three groups. The study managers of the entries in the first 2 groups will receive an e-mail with a selected nudge. 1 group serves as a control.
Experimental Design Details
Randomization Method
Stratified randomization: Three groups are formed, depending on the last change (6 to 12 month, 12 to 18 month, more than 18 month ) to the entry. Within the groups block randomization done in office via excel
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
750
Sample size: planned number of observations
750
Sample size (or number of clusters) by treatment arms
250 Nudge A Mail
250 Nudge B Mail
250 Controlgroup (no Mail)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

Documents

Document Name
AEARCTR-0011161 IPD Dataset
Document Type
other
Document Description
This Excel document contains the raw data.
The 756 data sets have been numbered consecutively.
Each data set contains the information:
Data set number
Creation date of the study record
Last modification date of the study record
Group into which the record was randomised
Whether the nudge email was undeliverable
Whether the nudge email was followed by an out-of-office note
Whether the record was deleted after the nudge
Whether a contact was made after the nudge email was sent
Whether a change was made to the record
Whether the record was registered
Whether the person responsible for the study logged into the DRKS system
Which type of registration (prospective/retrospective) took place
Which study type (Interventional(Non-Interventional) the record is.
How old the study entry was at the time of nudge.
File
AEARCTR-0011161 IPD Dataset

MD5: 2d28b2cae514669b1789114e9f3b6865

SHA1: adb9520f2418156223a5520f895235ae04ee977b

Uploaded At: September 11, 2023

IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
June 12, 2023, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
August 22, 2023, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
756
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
756
Final Sample Size (or Number of Clusters) by Treatment Arms
251 Persons responsible for studies Nudge A, 252 Persons responsible for studies Nudge B, 253 Persons responsible for studies control
Data Publication

Data Publication

Is public data available?
Yes

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials

Description
Master thesis: Nudging in clinical trial registration
Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. October 13. 2023. "Registration Entry Title: Master thesis: Nudging in clinical trial registration ." AEA RCT Registry. October 10 https://doi.org/10.1257/rct.11161-3.1
File
Masterarbeit-Lisa-Bieselt-Nudging-in-der-Registrierung-klinischer-Studien.pdf

MD5: c971a1bbde4bf0c123528e8ea2a7c81f

SHA1: 8f9e9a8ec57dc32502d95c44c34f7ff09463f5b7

Uploaded At: October 10, 2023

Description
Abstract: Nudging in clinical trial registration
Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. October 13. 2023. "Registration Entry Title: Abstract: Nudging in clinical trial registration." AEA RCT Registry. October 10 https://doi.org/10.1257/rct.11161-3.1
File
Abstract-Nudging-in-clinical-trial-registration.pdf

MD5: a44efd0a45ef1bf9b6447411a262f9bd

SHA1: b8e9cf89a3adb8bc7d7aa947335b33f37657578e

Uploaded At: October 10, 2023

Description
Mail Text Nudge A
Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. October 13. 2023. "Registration Entry Title: Mail Text Nudge A." AEA RCT Registry. October 13 https://doi.org/10.1257/rct.11161-3.1
File
Template-Mail-Nudge A.docx

MD5:

SHA1:

Uploaded At: October 13, 2023

Description
Mail Text Nudge B
Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. October 13. 2023. "Registration Entry Title: Mail Text Nudge B." AEA RCT Registry. October 13 https://doi.org/10.1257/rct.11161-3.1
File
Template-Mail-Nudge-B.docx

MD5:

SHA1:

Uploaded At: October 13, 2023