Skip to content

Efficacy of an evidence-based Informed Shared Decision Making program for prevention of myocardial infarction in type 2 diabetes

Efficacy of an evidence-based Informed Shared Decision Making program for prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84636255
Enrollment
154
Registered
2013-04-12
Start date
2013-03-12
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evidence-based patient information on the prevention of heart attack in type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Two study groups will be compared: Intervention group: ISDM program consisting of a decision aid booklet and a curriculum for group counseling. Control group: Placebo counseling, i.e. a program simi

Sponsors

European Foundation for the Study of Diabetes (EFSD) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients (men and women) are eligible with type 2 diabetes 2. Aged between 45 and 69 years 3. With no previous diagnosis of ischemic heart disease (ICD I20-I25) 4. With former participation in Decision Making (DMP) education programs for type 2 diabetes 5. HbA1c-values between 6 and 9%

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have: 1. Cognitive disorders 2. Proliferative retinopathy 3. Chronic kidney disease stage three or higher [Kidney Disease Outcomes Quality Initiative (KDOQI)] 4. Addiction to alcohol 5. Metastatic cancer

Design outcomes

Primary

MeasureTime frame
The patients' comprehension of heart attack prevention that includes the understanding of the concept of risk, the notion of heart attack risk, and the benefits and harms of preventative measures.

Secondary

MeasureTime frame
1. Adherence to the individual treatment goals regarding statin treatment, blood-pressure treatment, glucose control, and smoking cessation 2. Adherence to the preventative option prioritized by the individual patient

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026