Condition category
Respiratory
Date applied
15/09/2010
Date assigned
20/09/2010
Last edited
24/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://abd.ocbmedia.com

Contact information

Type

Scientific

Primary contact

Dr Monica Lakhanpaul

ORCID ID

Contact details

Leicester Medical School
Maurice Shock Medical Building
The University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)1162 522522
ml103@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An Acute Breathing Difficulties evidence based learning package: a cluster randomised controlled trial

Acronym

Study hypothesis

Does an online learning package incorporating an acute breathing difficulties (ABD) evidence based guideline can be a satisfactory and effective adjunct in reinforcing standard teaching received to incrementally increase undergraduate students' knowledge and self-assessed confidence

Ethics approval

The University of Leicester Research Ethics Officer; Dr. Rhona Knight approved on the 26th of November 2007

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not applicable

Condition

Acute breathing difficulties in children

Intervention

1. Intervention: Online learning package consisting of the primary outcome measures, a Royal College of Paediatrics and Child Health (RCPCH) -ratified evidence based guideline on the management of acute breathing difficulties and supporting descriptive, audio & video material
2. Control: Online learning package consisting of the primary outcome measures

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 24-item multiple choice question based assessment incorporating video case scenarios assessing knowledge of acute breathing difficulties
2. 7-item questionnaire utilising 5-point Likert scales assessing student’s self assessed confidence on a range of common paediatric skills

Secondary outcome measures

1. Knowledge retention 2-weeks after completion of the 7-week teaching rotation
2. Student satisfaction with the complete learning package

Overall trial start date

03/03/2008

Overall trial end date

20/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All medical students undertaking their paediatric clinical rotation during the study period

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Three clusters of 36 students per arm

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

03/03/2008

Recruitment end date

20/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Medical School
Leicester
LE1 7RH
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

c/o Prof Stewart Petersen
Leicester Medical School
Maurice Shock Medical Building
University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)1162 522946
sxp@le.ac.uk

Sponsor type

University/education

Website

http://www.le.ac.uk/

Funders

Funder type

University/education

Funder name

University of Leicester (UK)

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Leicester Postgraduate Deanery (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Both provided funding for development of ABD learning package. No funding sources for trial conduct.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23398452

Publication citations

  1. Results

    Manikam L, Blackwell N, Banerjee J, Nightingale P, Lakhanpaul M, Improving assessment of paediatric acute breathing difficulties in medical education: a cluster randomized controlled trial., Acta Paediatr., 2013, 102, 5, e205-9, doi: 10.1111/apa.12187.

Additional files

Editorial Notes