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

ISRCTN	ISRCTN10291077
DOI	https://doi.org/10.1186/ISRCTN10291077
Secondary identifying numbers	LT09-261

Submission date: 13/04/2010
Registration date: 17/11/2010
Last edited: 10/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Prof Andreas Soennichsen
Scientific

Institute of General Practice and Family Medicine
University of Witten/Herdecke
Alfred-Herrhausen-Str. 50
Witten
58448
Germany

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	SPEED
Study objectives	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(s)	Ethics Commission of the Province of Salzburg, Austria, 24/02/2010, ref: 415-E/1168/2-2010
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2010
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	330
Key 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
Key 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
Date of first enrolment	01/06/2010
Date of final enrolment	31/08/2013

Locations

Countries of recruitment

Austria
Germany

Study participating centre

University of Witten/Herdecke

Witten
58448
Germany

Sponsor information

International Diabetes Federation (IDF) (Belgium)
Research organisation

166 Chaussée de la Hulpe
Brussels
1170
Belgium

Phone	+32 (0)2 538 5511
Email	info@idf.org
Website	http://www.idf.org
"ROR"	https://ror.org/04t34tv83

Funders

Funder type

Research organisation

International Diabetes Federation (IDF) (Belgium) - BRIDGES programme (grant ref: LT09-261)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No

Editorial Notes

10/02/2016: Publication reference added.
19/07/2013: target number of participants changed from 660 to 330.
12/07/2013: overall trial end date changed from 31/05/2013 to 31/08/2013.