Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/01/2009
Date assigned
30/01/2009
Last edited
12/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dean Jenkins

ORCID ID

Contact details

Cardiff Medicentre
Heath Park
Cardiff
CF14 4UJ
United Kingdom
+44 (0)2920 757744
DJenkins@bmjgroup.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the effectiveness of using a Diabetes Needs Assessment Tool (DNAT) on health professionals' knowledge of diabetes and self-reported changes in clinical practice: a randomised controlled trial

Acronym

Study hypothesis

Amended as of 26/03/2009:
Aims:
1. To evaluate the effectiveness of using a new online Diabetes Needs Assessment Tool (DNAT) to improve knowledge of how to manage diabetes
2. To evaluate the acceptability of this format of learning
3. To evaluate self-reported changes in clinical practice as a result of this learning

Hypotheses:
1. Four months after being administered the online learning materials, learners in the intervention group will show greater diabetes knowledge and report higher levels of acceptability of the learning materials than learners in the control group
2. Five months after being administered the online learning materials, learners in the intervention group will report more changes to their clinical practice than learners in the control group

Initial information at the time of registration:
Aims:
1. To evaluate the effectiveness of using a new online Diabetes Needs Assessment Tool (DNAT) to improve knowledge of how to manage diabetes
2. To evaluate the acceptability of this format of learning
3. To evaluate self-reported changes in clinical practice as a result of this learning

Hypotheses:
1. Four months after being administered the online learning materials, learners in the intervention group will show greater knowledge change and report higher levels of acceptability of the learning materials than learners in the control group
2. Five months after being administered the online learning materials, learners in the intervention group will report more changes to their clinical practice than learners in the control group

Ethics approval

As of 11/02/2009 the REC for Wales has confirmed that the study does not require full ethical review

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes

Intervention

Both the control group and the intervention group will be given access to the same online Diabetes Learning Modules during a 4-month learning period. The Diabetes Learning Modules include:
1. Current evidence-based guidelines (particularly those of the European Society of Cardiology and the European Association for the Study of Diabetes [ESC-EASD] Guidelines on Diabetes, Pre-diabetes and Cardiovascular Disease)
2. Important clinical areas and common difficulties in practice
3. Type 1, Type 2, diabetes in pregnancy and secondary causes of diabetes
All content of these learning modules is applicable to European practice and material comes from BMJ Learning, Elsevier Health Sciences and the International Diabetes Federation.

In addition to the Diabetes Learning Modules, the intervention group will be administered the Diabetes Needs Assessment Tool (DNAT). The DNAT is a computerised adaptive test comprised of clinically rich case problems. On completion of the DNAT, a personalised learning report is created for each learner identifying their learning needs alongside individualised recommendations of the most appropriate Diabetes Learning Modules to meet those needs. At any stage this personalised report can be viewed listing the performance of the learner at that point.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Amended as of 26/03/2009:
Diabetes knowledge as measured by the Diabetes Knowledge Test at four months.

Initial information at the time of registration:
Change in knowledge scores on the Diabetes Knowledge Test from baseline (randomisation) to 4 months after administration of learning materials.

Secondary outcome measures

1. Acceptability of the learning materials measured by an electronic survey 4 months after being administered the learning materials
2. Self-reported changes in clinical practice measured by an electronic survey 5 months after being administered the learning materials

Overall trial start date

06/02/2009

Overall trial end date

25/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must be either English or German speaking practising doctors or nurses (approximately 20 - 65 years, either sex) managing at least one patient with diabetes a week.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Doctors and nurses not managing at least one patient with diabetes a week.

Recruitment start date

06/02/2009

Recruitment end date

25/09/2009

Locations

Countries of recruitment

Germany, United Kingdom

Trial participating centre

Cardiff Medicentre
Cardiff
CF14 4UJ
United Kingdom

Sponsor information

Organisation

BMJ Group (UK)

Sponsor details

c/o Mrs Vanessa Edmonds
BMA House
Tavistock Square
London
WC1H 9JR
United Kingdom
+44 (0)20 7383 6567
vedmonds@bmjgroup.com

Sponsor type

Industry

Website

http://group.bmj.com/

Funders

Funder type

Industry

Funder name

Merck Sharp and Dohme Regional Business Support Center (MSD RBSC) GmbH (Germany) - involved in design of study but no access to data or statistical analyses

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BMJ Group (UK) - not involved in statistical analyses

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

2009 protocol in http://www.ncbi.nlm.nih.gov/sites/pubmed/19642984

Publication citations

Additional files

Editorial Notes