Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/04/2010
Date assigned
17/11/2010
Last edited
10/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://aktivtreff.com

Contact information

Type

Scientific

Primary contact

Prof Andreas Soennichsen

ORCID ID

Contact details

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

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 measures

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

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

http://www.idf.org

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26858958

Publication citations

Additional files

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.