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 |
| Protocol serial number | LT09-261 |
| Sponsor | International Diabetes Federation (IDF) (Belgium) |
| Funder | International Diabetes Federation (IDF) (Belgium) - BRIDGES programme (grant ref: 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
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
Contact information
Scientific
Institute of General Practice and Family Medicine
University of Witten/Herdecke
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant 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(s) |
Current primary outcome measures as of 12/07/2013: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 12/07/2013: |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
58448
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
