UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013822 |
|---|---|
| Receipt number | R000016130 |
| Scientific Title | A Double-Blind Randomised Controlled Trial of Critical Clinical Information Recall in Fatigued Clinicians: Structured Cues or Neuropharmacology ? |
| Date of disclosure of the study information | 2014/04/27 |
| Last modified on | 2014/04/27 20:33:41 |
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Basic information
Public title
A Double-Blind Randomised Controlled Trial of Critical Clinical Information Recall in Fatigued Clinicians:
Structured Cues or Neuropharmacology ?
Acronym
Recall in Fatigued Clinicians
Scientific Title
A Double-Blind Randomised Controlled Trial of Critical Clinical Information Recall in Fatigued Clinicians:
Structured Cues or Neuropharmacology ?
Scientific Title:Acronym
Recall in Fatigued Clinicians
Region
| Europe |
Condition
Condition
Fatigue
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to assess the influence of neuropharmological enhancement in performance amongst non-sleep deprived fatigued doctors. Specifically, we investigate the impact of modafinil on the amount of clinical information freely recalled and recalled following cue-based memory improvement interventions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3
Key secondary outcomes
2
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Placebo:
Interventions/Control_2
200mg Modafinil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
medical trainee
Key exclusion criteria
Exclusion criteria was a history of neurocognitive impairment; consumption of >twenty-one units of alcohol/week; positive scores on the CAGE or Epworth questionnaire; illicit drug use; or consumption of more than three caffeinated drinks/day.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof Ara Darzi |
Organization
Imperial College London
Division name
Department of Cancer and Surgery
Zip code
Address
1
TEL
442033126666
a.darzi@imperial.ac.uk
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Prof Ara Darzi |
Organization
Imperial College London
Division name
Department of Cancer and Surgery
Zip code
Address
1
TEL
442033126666
Homepage URL
a.darzi@imperial.ac.uk
Sponsor or person
Institute
Imperial College London
Institute
Department
Personal name
Funding Source
Organization
Imperial College London
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
UK
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Imperial College London
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 27 | Day |
Last modified on
| 2014 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016130
