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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013822
Receipt No. 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

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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
Email 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
Email a.darzi@imperial.ac.uk

Sponsor
Institute Imperial College London
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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