Towards a more cost-effective diabetes control in primary care: the EFFIMODI (EFFIcient MOnitoring of DIabetes) trial
| ISRCTN | ISRCTN93201802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93201802 |
| Secondary identifying numbers | 80-82310-98-09058 |
- Submission date
- 02/06/2009
- Registration date
- 14/07/2009
- Last edited
- 25/04/2014
- 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
Miss Paulien Renske Wermeling
Scientific
Scientific
University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)88 75 686 40 |
|---|---|
| P.Wermeling@umcutrecht.nl |
Study information
| Study design | Single centre randomised controlled patient-preference equivalence trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| 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 | Six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes mellitus: a randomised, controlled, patient-preference equivalence trial in primary care |
| Study acronym | EFFIMODI |
| Study objectives | As of 30/03/2010 this record has been updated; all changes can be found in the relevant field with the above update date. Current primary objective as of 30/03/2010: Does six-monthly monitoring of well controlled people with type 2 diabetes mellitus (DM2) in primary care lead to equivalent cardiometabolic control as three-monthly monitoring? Initial primary objective at time of registration: Does six-monthly monitoring of well controlled people with type 2 diabetes mellitus (DM2) in primary care lead to equivalent glycaemic control as three-monthly monitoring? Secondary objectives: 1. What are the costs of six-monthly follow up of DM2 patients compared with three-monthly follow up? 2. In case the three-monthly follow up is more effective than the six-monthly follow up: what is the incremental cost-effectiveness of three-monthly versus six-monthly follow up of DM2 patients in general practice? |
| Ethics approval(s) | Medical Research Ethics Committee (MREC) Utrecht approved on the 17th March 2009 (ref: 08-453, CCMO number: NL25787 041 08) |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Control: three-monthly diabetes monitoring by general practitioner and practice nurse Intervention: six-monthly diabetes monitoring by general practitioner and practice nurse The intervention will last one and a half year. |
| Intervention type | Other |
| Primary outcome measure | Current information as of 30/03/2010: Percentage of people that remains under good cardiometabolic control, defined as having HbA1c less than or equal to 7.5% and systolic blood pressure less than or equal to 145 mmHg and total cholesterol less than or equal to 5.2 mmol/l. HbA1c, systolic blood pressure and total cholesterol will be collected from the general practitioners' Information System. Initial information at time of registration: Change in glycaemic control, expressed as the mean change in HbA1c percentage between baseline and follow-up. HbA1c will be collected from the general practitioners' Information System. |
| Secondary outcome measures | Differences in: 1. Blood pressure, collected from the general practitioners Information System 2. Body mass index, collected from the general practitioners Information System 3. Cholesterol, collected from the general practitioners Information System 4. Fasting blood glucose, collected from the general practitioners Information System 5. Lifestyle factors (smoking behaviour, physical activity), measured using the SQUASH questionnaire before and after the intervention period 6. Patients' quality of life, measured using the 36-item Short Form Health Survey (SF-36) and EuroQoL questionnaire (EQ5D) before and after the intervention period 7. Diabetes-specific distress, measured using the Problem Areas In Diabetes (PAID) questionnaire before and after the intervention period 8. Satisfaction with care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) before and after the intervention period 9. Adherence with medications, collected from the general practitioners Information System Added as of 30/03/2010: 10. HbA1c, collected from the general practitioners' Information System |
| Overall study start date | 16/04/2009 |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2250 participants (1125 in preference arm, 1125 in randomised arm) |
| Key inclusion criteria | 1. People with DM2 2. Aged 40 - 80 years, either sex 3. Treated by their general practitioner |
| Key exclusion criteria | Contraindications for less frequent than three-monthly monitoring: 1. Duration of DM2 for less than one year 2. Insulin treatment 3. HbA1c greater than 7.5% 4. Systolic blood pressure greater than 145 mmHg 5. Total cholesterol greater than 5.2 mmol/L |
| Date of first enrolment | 16/04/2009 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)88 75 681 54 |
|---|---|
| juliuscenter@umcutrecht.nl | |
| Website | http://www.juliuscentrum.nl |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09058)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/05/2010 | Yes | No | |
| Results article | satisfaction results | 30/07/2013 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No |
