Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Integrated care-based education intervention to improve glycaemic control and blood pressure in patients with microalbuminuria from a mixed ethnic population: a randomised controlled trial
Acronym
MEMO
Study hypothesis
This four-year study will examine the benefits of combining medication optimisation with structured self-management education in a multi-ethnic community, for individuals with microalbuminuria and type 2 diabetes.
Ethics approval
Leicestershire Research Ethics Committee, 05/09/2005, ref: 05/Q2501/34
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes mellitus/nephropathy
Intervention
Intervention arm:
Participants attend group education sessions. Initially they are offered a basic programme of 6 hours around basic diabetes. They then attend a 3-hour session on diabetes and the kidney - they are then given the opportunity to opt into sessions depending on the risk factors they wish to target such as blood pressure, weight management, lipids, blood glucose. In addition to this participants are seen on a one to one basis with a clinician/nurse who titrates medications for glucose, blood pressure and lipids if necessary and sets individualised goals with the participants. Participants are seen at 3, 6, 9 and 12 months and then 6-monthly thereafter.
Control arm:
Patients receive usual care but attend the research centre for clinical measurements at 6, 12, 18, 24 months and yearly thereafter.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
HbA1c at 18 months.
Secondary outcome measures
1. Cardiovascular events at 4 years
2. Mortality at 4 years
3. Biochemical measured at baseline and 6, 12, 18, 24, 36, 48 months
4. Blood pressure measured at baseline and 6, 12, 18, 24, 36, 48 months
5. Blood lipids measured at baseline and 6, 12, 18, 24, 36, 48 months
6. HbA1c measured at baseline and 6, 12, 18, 24, 36, 48 months
7. Medication use measured at baseline and 6, 12, 18, 24, 36, 48 months
8. Urinary albumin excretion measured at baseline and 18, 24, 36 and 48 months
9. Serum creatinine and urea levels measured at baseline and 6, 12, 18, 24, 36, 48 months
10. Smoking status measured at baseline and 6, 12, 18, 24, 36, 48 months
11. Physical activity measured at baseline and 6, 12, 18, 24, 36, 48 months
12. Quality of life measured at baseline and 6, 12, 18, 24, 36, 48 months
13. Medication beliefs measured at baseline and 6, 12, 18, 24, 36, 48 months
14. Depression measured at baseline and 6, 12, 18, 24, 36, 48 months
15. Personality measured at baseline
Overall trial start date
01/09/2005
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 25 - 80 years, either sex
2. A confirmed diagnosis of type 2 diabetes on diet, tablets or insulin
3. Microalbuminuria or proteinuria
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
189
Participant exclusion criteria
1. A malignancy
2. Liver disease
3. An autoimmune disease
4. Any life threatening condition with a life expectancy of less than 5 years
5. Immobility (difficult to attend sessions)
6. Learning disability or mental incapacity
7. Serum creatinine greater than 180 µmol/l
8. Patients taking part in another research study
Recruitment start date
01/09/2005
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Diabetes Centre (Broadleaf)
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust
Sponsor details
Leicester General Hospital
Gwendolen Road
Leicester
LE9 8HZ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Kidney Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
31/12/2011
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21640424