To determine whether the generally recommended three-monthly follow up in the usual diabetes care in general practice can be reduced to six-monthly follow up for some of the patients.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glycemic control, expressed as HbA1c%.
Secondary outcome
Blood pressure, body mass index, cholesterol, patients* quality of life and
distress, satisfaction with care, costs.
Background summary
Scientific evidence for the frequency of monitoring of type 2 diabetes mellitus
(DM2) patients is lacking. If the standard three-monthly control in general
practice can be reduced to six-monthly control, this would on the one hand
reduce the use of medical services, and thus reduce costs, and on the other
hand alleviate the burden of people with DM2.
Study objective
To determine whether the generally recommended three-monthly follow up in the
usual diabetes care in general practice can be reduced to six-monthly follow up
for some of the patients.
Study design
Randomised, controlled equivalence trial; patient preference trial.
Participants are asked if they have a strong preference for continuing the
current care. If not, they will be randomised into a group that receives
three-monthly follow up and a group that receives six-monthly follow up. If
they prefer continuing the current care, they will be included in the
preference arm and thus receive three-monthly follow up.
Repeated measures analysis will be used to be able to optimally use all data
available. For outcomes that have only baseline and final measurements, ANCOVA
will be used. Furthermore, a cost-minimisation analysis or a cost-effectiveness
analysis will be carried out, depending on the results of the intervention
trial.
Intervention
Six-monthly follow up in DM2 care by the same team (GP, practice nurse/diabetes
nurse, practice assistant) and with the same targets according to Dutch
guidelines instead of standard three-monthly monitoring.
Study burden and risks
The patients will fill out a questionnaire twice, with a total duration of 90
minutes. There is no risk associated with participation in the trial.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- People with type 2 diabetes mellitus;
- Aged 40-80 years;
- Treated by their general practitioner.
Exclusion criteria
Contra-indications for less frequent than three-monthly monitoring:
- Duration of type 2 diabetes mellitus for less than one year;
- Insulin treatment;
- HbA1c >7.5%;
- Systolic blood pressure >145 mmHg;
- Total cholesterol >5.2 mmol/L.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25787.041.08 |