Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0171135935
Study information
Scientific title
Acronym
Study hypothesis
Diabetes mellitus is a common condition whose prevalence is increasing. It is estimated that the number of diabetics worldwide will double by the year 2010.
1. This is primarily as a result of the increasing prevalence of type 2 diabetes.
2. The cost of managing diabetes is also high with 5% of the total NHS resources and up to 10% of hospital in-patient resources being used to care for those with this chronic disease.
The focus of care for chronic diseases such as diabetes is now directed towards risk factor management and the prevention of complications. With this shift of emphasis patient education and empowerment has advanced from being an adjunct to medical therapy to an intervention in its own right.
Few educational initiatives aimed at type 2 diabetic patients in a primary care setting have been carried out in the UK.
3. Control of cardiovascular risk factors has been identified as having a key role in the prevention of macro-vascular complications in type 2 diabetes.
4. Evidence exists indicating the importance of lipid lowering therapy and maintaining satisfactory cholesterol levels in diabetic patients.
5. However there is a paucity of evidence on the effectiveness of educational interventions focusing on this risk factor.
This pilot study will examine and compare the effect of a patient education intervention, aimed at the satisfactory control of cholesterol in type 2 diabetic patients with usual care. It will employ a randomised control trial design.
The study hypothesis to be answered is whether an intervention based on adult educational and behavioural principles, aimed at type 2 diabetic patients, will improve patient knowledge of cholesterol control and improve physiological measurement of cholesterol.
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
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Type II diabetes
Intervention
Please note that as of 29/09/10 this status of this record has been changed to 'Stopped' due to the departure of the Primary Investigator from the trial.
1. Educational intervention plus usual care
2. Usual care
Patients from the same household will be allocated to the same group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Serum lipid profiles
2. Measurement of disease related knowledge with particular reference to cholesterol control
Secondary outcome measures
1. Serum HbAlc
2. Body mass index
3. Blood pressure
4. Number of cholesterol lower medication alterations or initiations
Overall trial start date
01/12/2003
Overall trial end date
01/07/2004
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
1. Age range: 18-80
2. Men and/or women: men and women
3. Type 2 diabetic
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 (15 per group)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/12/2003
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Primary Care
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Nottingham Primary Care Research Partnership (UK)
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