Plain English Summary
Background and study aims
Patient self-management and peer support are promising new approaches in diabetes care. This study will show whether peer support including occasional professional support can help people with type 2 diabetes improve their quality of life.
Who can participate?
A total of 77 GP surgeries and 1327 patients currently enrolled in the "Therapie aktiv" disease management programme in the province of Salzburg are invited to participate.
What does the study involve?
Participants will be randomly allocated into either the intervention group or the control group. Participants in the intervention group will take part in a peer support programme, which consists of regular group meetings of patients with type 2 diabetes run by trained peer supporters. They will exercise together, talk about medical, nutritional, personal, social and emotional issues regarding diabetes, and will receive occasional support from doctors, dieticians, diabetes nurses, clinical psychologists and physical education trainers. Those allocated to the control group will receive usual care within the disease management programme.
What are the possible benefits and risks of participating?
The possible benefits include higher quality of life, better control of blood pressure and weight loss.
Where is the study run from?
Paracelsus Medical University (Austria)
When is the study starting and how long is it expected to run for?
June 2010 to August 2013
Who is funding the study?
International Diabetes Federation (Belgium)
Who is the main contact?
Andreas Sönnichsen
Andreas.soennichsen@uni-wh.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LT09-261
Study information
Scientific title
Effectiveness of a peer support program versus care as usual in disease management regarding improvement of metabolic control and diabetes management self-efficacy: a cluster-randomised controlled trial
Acronym
SPEED
Study hypothesis
As an additional component of disease management the peer support program Di-AKTIV improves metabolic control, patient self-management efficacy, risk profile and quality of life of patients with diabetes mellitus type 2.
Ethics approval
Ethics Commission of the Province of Salzburg, Austria, 24/02/2010, ref: 415-E/1168/2-2010
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus type 2
Intervention
1. Intervention group:
Peer support group meetings and exercise modules (1h per week). Patients will be encouraged to further daily exercising. The aim is to achieve at least an exercise level of 1000 kcal/week. A handbook regarding the following topics will be given to the peer groups:
1.1. daily management and living with diabetes
1.2. basic understanding of diabetes and diabetes care
1.3. diabetic medication
1.4. nutrition and diabetes
1.5. physical exercise, specifically motivational problems that may lead to less exercising than recommended
1.6. cardiovascular risk management
1.7. diabetic foot care and prevention
1.8. prevention of diabetic complications
Peer groups will get professional guidance by nutritionists, doctors, sports instructors and psychologists twice a year by each
2. Control group:
Usual care within the Disease Management Programme "Therapie aktiv"
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 12/07/2013:
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
Previous primary outcome measures:
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
Current secondary outcome measures as of 12/07/2013:
1. Higher quality of life
2. Improved control of cardiovascular risk factors (hypertension, hyperlipidemia)
3. Lowering of global cardiovascular risk
4. Weight (body mass index [BMI]) reduction
5. Increased smoking cessation
The secondary outcomes will be measured between 01/10/2010-31/07/2011 (baseline) and 01/10/2010-31/07/2013 (end of intervention).
Previous secondary outcome measures:
1. Improved diabetes management self-efficacy
2. Higher quality of life
3. Improved control of cardiovascular risk factors (hypertension, hyperlipidemia)
4. Lowering of global cardiovascular risk
5. Weight (body mass index [BMI]) reduction
6. Increased smoking cessation
The secondary outcomes will be measured between 01/10-31/12/2010 (baseline) and 01/10-31/12/2012 (end of intervention).
Overall trial start date
01/06/2010
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant 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
Recruitment start date
01/06/2010
Recruitment end date
31/08/2013
Locations
Countries of recruitment
Austria
Trial participating centre
University of Witten/Herdecke
Witten
58448
Germany
Sponsor information
Organisation
International Diabetes Federation (IDF) (Belgium)
Sponsor details
166 Chaussée de la Hulpe
Brussels
1170
Belgium
+32 (0)2 538 5511
info@idf.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
International Diabetes Federation (IDF) (Belgium) - BRIDGES programme (grant ref: LT09-261)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26858958