Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/07/2005
Date assigned
25/07/2005
Last edited
16/09/2009
Prospective/Retrospective
Retrospectively 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 Robbie Foy

ORCID ID

Contact details

Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 7214

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005DIAB002

Study information

Scientific title

Acronym

Study hypothesis

In general practices receiving glycaemic educational messages attached to laboratory test reports, compared to those practices not, the number of HbA1c test requests will be higher and the mean HbA1c value will be lower. Similarly for cholesterol messages the number of cholesterol tests will be higher and the mean cholesterol value will be lower.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Diabetes mellitus

Intervention

Short educational messages added to paper and electronic general practice laboratory test reports of Haemoglobin A1c (HbA1c).
Practices, stratified by list size, will be randomly allocated to each intervention (glycaemic control educational messages and cholesterol control educational messages) independently. In the first randomisation, practices will be allocated to receive the glycaemic educational messages or control (no glycaemic educational messages). In the second randomisation, practices will be allocated to receive the cholesterol educational messages or control (no cholesterol educational messages). This will result in four groups:
1. Practices receiving glycaemic and cholesterol educational messages
2. Practices receiving only glycaemic educational messages
3. Practices receiving only cholesterol educational messages
4. Practices receiving no educational messages
This will allow comparisons of the separate and combined effects of the two educational message interventions.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of HbA1c and cholesterol tests requested (standardised for practice size) and the general practice mean levels of HbA1c and cholesterol.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2005

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

General practices in Newcastle upon Tyne

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

39 practices

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2005

Recruitment end date

31/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Organisation

Newcastle Primary Care NHS Trust (UK)

Sponsor details

Research and Development Department
Benfield Road
Newcastle upon Tyne
NE6 4PF
United Kingdom
+44 (0)191 219 6132
alison.emslie@newcastle-pct.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Newcastle Primary Care NHS Trust (UK) (ref: 2005DIAB002) - The funding comes from service development rather than NHS R&D monies.

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

2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17650309

Publication citations

  1. Protocol

    Foy R, Hawthorne G, Gibb I, Eccles MP, Steen N, Hrisos S, White T, Croal BL, Grimshaw JM, A cluster randomised controlled trial of educational prompts in diabetes care: study protocol., Implement Sci, 2007, 2, 22, doi: 10.1186/1748-5908-2-22.

Additional files

Editorial Notes