Contact information
Type
Scientific
Primary contact
Miss Paulien Renske Wermeling
ORCID ID
Contact details
University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)88 75 686 40
P.Wermeling@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
80-82310-98-09058
Study information
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
Acronym
EFFIMODI
Study hypothesis
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
Medical Research Ethics Committee (MREC) Utrecht approved on the 17th March 2009 (ref: 08-453, CCMO number: NL25787 041 08)
Study design
Single centre randomised controlled patient-preference equivalence trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
16/04/2009
Overall trial end date
01/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. People with DM2
2. Aged 40 - 80 years, either sex
3. Treated by their general practitioner
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2250 participants (1125 in preference arm, 1125 in randomised arm)
Participant 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
Recruitment start date
16/04/2009
Recruitment end date
01/06/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Center Utrecht (UMCU) (Netherlands)
Sponsor details
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)88 75 681 54
juliuscenter@umcutrecht.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09058)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20459820
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24635880
2014 satisfaction results in: http://www.ncbi.nlm.nih.gov/pubmed/23899039
Publication citations
-
Protocol
Wermeling PR, van den Donk M, Gorter KJ, Ardine de Wit G, van der Graaf Y, Rutten GE, Towards a more efficient diabetes control in primary care: six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes - The EFFIMODI trial. Design of a randomised controlled patient-preference equivalence trial in primary care., BMC Fam Pract, 2010, 11, 35, doi: 10.1186/1471-2296-11-35.
-
Results
Wermeling PR, Gorter KJ, Stellato RK, de Wit GA, Beulens JW, Rutten GE, Effectiveness and cost-effectiveness of 3-monthly versus 6-monthly monitoring of well-controlled type 2 diabetes patients: a pragmatic randomised controlled patient-preference equivalence trial in primary care (EFFIMODI study)., Diabetes Obes Metab, 2014, 16, 9, 841-849, doi: 10.1111/dom.12288.
-
Satisfaction results
Wermeling PR, Janssen J, Gorter KJ, Beulens JW, Rutten GE, Satisfaction of well-controlled type 2 diabetes patients with three-monthly and six-monthly monitoring., BMC Fam Pract, 2013, 14, 107, doi: 10.1186/1471-2296-14-107.