The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system.
Completed
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- NL-OMON24877
- Lead Sponsor
- EMGO Institute VU University Medical CenterVan der Boechorststraat 71081 BT AmsterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Patients with type 2 diabetes from general practices with the support of a practice nurse;
2. Age 40-70 years;
Exclusion Criteria
1. Unstable endocrine disorders, with the exception of diabetes;
2. Malignant disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Differences between intervention and usual care groups in changes in diet, physical activity and smoking behaviour according to the ASE-model, a health behaviour model that assumes that behaviour is determined by attitude (A), social influences (S) and self-efficacy (E); <br /><br>2. Changes in cardiovascular risk score based on the Oxford Risk Engine (algorithm that includes: age at diagnosis, duration of diabetes, sex, ethnicity, smoking status, systolic blood pressure, HbA1c, total cholesterol, HDL-cholesterol). A risk reduction of 5% is clinical relevant.
- Secondary Outcome Measures
Name Time Method 1. Quality of life;<br /><br>2. Patient satisfaction;<br /><br>3. Changes in medication use, adherence to prescribed medication;<br /><br>4. Proportion of patients reaching treatment targets according to the guidelines of the Dutch College of General practitioners;<br /><br>5. Adherence to the 3-monthly visit to the general practitioner.