A pilot study involving a randomised controlled trial of an educational intervention designed to improve cholesterol control in patients with type 2 diabetes.

ISRCTN	ISRCTN92478335
DOI	https://doi.org/10.1186/ISRCTN92478335
Protocol serial number	N0171135935
Sponsor	Department of Health
Funder	Nottingham Primary Care Research Partnership (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 29/09/2010

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christopher David
Scientific

Division of Primary Care
Room 1307
Tower Building
Nottingham University
Nottingham
NG7 2RD
United Kingdom

Phone	+44 (0)115 8466938

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Serum lipid profiles 2. Measurement of disease related knowledge with particular reference to cholesterol control
Key secondary outcome measure(s)	1. Serum HbAlc 2. Body mass index 3. Blood pressure 4. Number of cholesterol lower medication alterations or initiations
Completion date	01/07/2004
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Age range: 18-80 2. Men and/or women: men and women 3. Type 2 diabetic
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/12/2003
Date of final enrolment	01/07/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Primary Care

Nottingham
NG7 2RD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan