Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher David

ORCID ID

Contact details

Division of Primary Care
Room 1307
Tower Building
Nottingham University
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 8466938

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes