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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | MEMO |
| Study objectives | 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(s) | Leicestershire Research Ethics Committee, 05/09/2005, ref: 05/Q2501/34 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2005 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 189 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Diabetes Centre (Broadleaf)
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Leicester
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Leicester General Hospital
Gwendolen Road
Leicester
LE9 8HZ
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Kidney Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2011 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
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.
