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
Protocol serial number	80-82310-98-09058
Sponsor	University Medical Center Utrecht (UMCU) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 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

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
Email	P.Wermeling@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled patient-preference equivalence trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2250
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	satisfaction results	30/07/2013		Yes	No
Results article	results	01/09/2014		Yes	No
Protocol article	protocol	11/05/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes