Medication, Education and Medication Optimisation: improving glycaemic control and blood pressure in patients with microalbuminuria from a mixed ethnic population

ISRCTN ISRCTN83140074
DOI https://doi.org/10.1186/ISRCTN83140074
Protocol serial number N/A
Sponsor University Hospitals of Leicester NHS Trust
Funder Kidney Research UK
Submission date
23/03/2009
Registration date
30/03/2009
Last edited
26/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Melanie Davies
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleIntegrated care-based education intervention to improve glycaemic control and blood pressure in patients with microalbuminuria from a mixed ethnic population: a randomised controlled trial
Study acronymMEMO
Study objectivesThis 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(s)Leicestershire Research Ethics Committee, 05/09/2005, ref: 05/Q2501/34
Health condition(s) or problem(s) studiedType 2 diabetes mellitus/nephropathy
InterventionIntervention 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 typeOther
Primary outcome measure(s)

HbA1c at 18 months.

Key secondary outcome measure(s)

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

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration189
Key inclusion criteria1. Aged 25 - 80 years, either sex
2. A confirmed diagnosis of type 2 diabetes on diet, tablets or insulin
3. Microalbuminuria or proteinuria
Key exclusion criteria1. 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
Date of first enrolment01/09/2005
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

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.

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