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

Not Applicable

Completed

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

• Registration Number: ISRCTN77300204
• Lead Sponsor: European Foundation for the Study of Diabetes

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25887378 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30552272 (added 06/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-05
• Study Completion: 2016-07-01
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 279

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Informed choice regarding statin treatment, blood pressure control, glucose control, and smoking cessation<br> 2. The achievement of treatment goals regarding statin treatment, blood pressure, HbA1c, and smoking cessation<br> 3. Prioritisation of treatment goals<br> 4. Realistic expectations on the individual heart attack risk and on probabilities of benefits and harms of the available treatment options<br> 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<br>