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 |
| Secondary identifying numbers | N0171135935 |
- 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
Scientific
Division of Primary Care
Room 1307
Tower Building
Nottingham University
Nottingham
NG7 2RD
United Kingdom
| Phone | +44 (0)115 8466938 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 | 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 study start date | 01/12/2003 |
| 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 | Both |
| Target number of participants | 30 (15 per group) |
| 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
- England
- United Kingdom
Study participating centre
Division of Primary Care
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Nottingham Primary Care Research Partnership (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
