Self-Efficacy and Peer Support Enhance the Effectiveness of Disease Management in Diabetes Type 2 (SPEED)

Completed

• Conditions: Diabetes mellitus type 2; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN10291077
• Lead Sponsor: International Diabetes Federation (IDF) (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Patients with diabetes mellitus type 2 (American Diabetes Association [ADA]/World Health Organization [WHO] criteria)
2. Currently enrolled in the disease management programme (DMP) called Therapie aktiv
3. Aged greater than 18 years, either sex

Exclusion Criteria

1. Refusal or withdrawal of consent
2. Dementia or major psychiatric illness
3. Advanced neoplastic disease or other diseases with drastically reduced life expectancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 12/07/2013:<br>Decrease in HbA1c in the intervention group compared to controls, to be measured between 01/10/2010-31/07/2011 (baseline) and 01/10/2010-31/07/2013<br><br>Previous primary outcome measures:<br>Decrease in HbA1c in the intervention group compared to controls, to be measured between 01/10-31/12/2010 (baseline) and 01/10-31/12/2012 (end of intervention).

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 12/07/2013:<br>1. Higher quality of life<br>2. Improved control of cardiovascular risk factors (hypertension, hyperlipidemia)<br>3. Lowering of global cardiovascular risk<br>4. Weight (body mass index [BMI]) reduction<br>5. Increased smoking cessation<br>The secondary outcomes will be measured between 01/10/2010-31/07/2011 (baseline) and 01/10/2010-31/07/2013 (end of intervention).<br><br>Previous secondary outcome measures:<br>1. Improved diabetes management self-efficacy<br>2. Higher quality of life<br>3. Improved control of cardiovascular risk factors (hypertension, hyperlipidemia)<br>4. Lowering of global cardiovascular risk<br>5. Weight (body mass index [BMI]) reduction<br>6. Increased smoking cessation<br>The secondary outcomes will be measured between 01/10-31/12/2010 (baseline) and 01/10-31/12/2012 (end of intervention).