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
-
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.