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An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care.

An Informed Shared Decision Making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: a cluster randomised, controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77300204
Enrollment
306
Registered
2015-03-05
Start date
2014-12-16
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Type 2 diabetes, prevention of myocardial infarction, patient education, shared decision making Circulatory System Myocardial infarction

Interventions

Intervention group: ISDM programme comprising (1) an evidence-based patient decision aid on the prevention of myocardial infarction, (2) a structured teaching module provided by medical assistants, (

Sponsors

European Foundation for the Study of Diabetes
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Primary care practices are eligible if they meet the following criteria: 1. Employ at least one diabetes educator or a medical assistant or a nurse with further training in structured diabetes education 2. Provide structured teaching and treatment within the Disease Management Programme for patients with type 2 diabetes Patients are eligible if they meet the following criteria: 1. Age between 40 and 69 2. Type 2 diabetes 3. HbA1c-value less than 9% 4. Previous participation in structured treatment and teaching sessions as they are typically provided within the Disease Menagement Programme

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of ischaemic heart disease (ICD I20-I25), 2. Stroke (ICD I63) 3. Proliferative retinopathy 4. Chronic kidney disease stage 3 or higher 5. Metastatic cancer 6. Addicted to alcohol 7. Cared by a legal guardian

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is defined as the adherence to blood pressure drug treatment or if not applicable the adherence to statin treatment. This primary outcome measure is operationalised as adherence to drug prescriptions at six months follow-up. Telephone interviews will be conducted to assess the adherence to the current drug prescriptions.

Secondary

MeasureTime frame
1. Informed choice regarding statin treatment, blood pressure control, glucose control, and smoking cessation 2. The achievement of treatment goals regarding statin treatment, blood pressure, HbA1c, and smoking cessation 3. Prioritisation of treatment goals 4. Realistic expectations on the individual heart attack risk and on probabilities of benefits and harms of the available treatment options 5. The level of patient knowledge and understanding relating to the concept of risk, the notion of heart attack risk, and the benefits and harms of preventive treatment

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026