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.
BACKGROUND
Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring.


METHODS
The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c < or = 7.5%, systolic blood pressure < or = 145 mmHg and total cholesterol < or = 5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done.


CONCLUSIONS
This study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.
Wermeling
Paulien R
PR
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands. P.Wermeling@umcutrecht.nl
van den Donk
Maureen
M
Gorter
Kees J
KJ
Ardine de Wit
G
G
van der Graaf
Yolanda
Y
Rutten
Guy Ehm
GE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000503:physiopathology / Q000517:prevention & control*; D004180:Direct Service Costs; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods* / Q000592:standards; D009819:Office Visits; D057240:Patient Preference; D011320:Primary Health Care / Q000191:economics / Q000379:methods* / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors
D002784:Cholesterol; D006442:Glycated Hemoglobin
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