Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/06/2009
Date assigned
14/07/2009
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.juliuscentrum.nl

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes