Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/03/2009
Date assigned
30/03/2009
Last edited
26/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Melanie Davies

ORCID ID

Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

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 measures

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

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

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Charity

Funder name

Kidney Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21640424

Publication citations

Additional files

Editorial Notes

26/02/2016: Publication reference added. 30/07/2012: The overall end date of has been updated from 01/04/2011 to 30/09/2011.