SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborators:
Menarini Group
Deutsche Diabtesstiftung, Germany
Information provided by:
German Diabetes Association
ClinicalTrials.gov Identifier:
NCT00391040
First received: October 20, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 20, 2006
October 20, 2006
November 2003
Not Provided
HbA1c decrease, reduction of hypoglycemia, acute complications
Same as current
No Changes Posted
treatment satisfaction, ability for diabetes management, diabetes knowledge
Same as current
Not Provided
Not Provided
 
SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus
SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus - a Prospective Randomized Controlled Multicenter Trial

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

Patient education has become an integral part of any diabetes therapy in Germany. But elderly people are often not able to follow the variety of topics comprising standard treatment and training programmes for insulin-treated patients with type 2 diabetes mellitus due to geriatric syndromes and neuropsychological deficits. Therefore, treatment of elderly diabetics should focus on individual therapeutic goals, which reflect reduced life expectancy and quality of life.

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

The high prevalence of cognitive impairment and affective disorders requires special pedagogical methods as well as adapted contents. For example the advantages of physical activity, the frequent existence of malnutrition, urinary incontinency or heart failure are taken into consideration. Contents are transmitted in a practical and daily-living oriented way.

The programme comprises 7 education lessons of 45 minutes duration implying the education units: diabetes mellitus, nutrition, treatment strategies, self-monitoring and complications focussing the diabetic foot syndrome.

The effectiveness of the new structured treatment and teaching programme SGS was evaluated in a multicenter prospective randomised controlled trial. Diabetic patients admitting one of 18 study centres in Germany with at least one geriatric syndrome, comorbidity and older than 65 years were randomised either to the new SGS programme or to the standard treatment programme for patients with type 2 diabetes mellitus. Before and 6 month after participation in the structured treatment programmes the outcome quality was evaluated using structured questionnaires. We assessed HbA1c, skills of diabetes self-management, diabetes knowledge, treatment satisfaction, acute and late complications, neuropsychological status, diabetes mediation, activities of daily living and need of social service. The main treatment goal was maintenance of autonomy and quality of life in elderly people, as well as prevention of catabolism, frailty and acute complications.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Diabetes Mellitus
Behavioral: SGS education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2006
Not Provided

Inclusion Criteria:

  • Age older than 65 years, at least more than one other diagnosis than diabetes, at least one geriatric syndrome

Exclusion Criteria:

  • myocardial infarction, apoplexy within the last 2 weeks before planned enrolment
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00391040
1201-10/03
Not Provided
Not Provided
German Diabetes Association
  • Menarini Group
  • Deutsche Diabtesstiftung, Germany
Principal Investigator: Andrej Zeyfang, MD German Diabetes Association- Working Group Diabetes and Geriatrics
Study Chair: Anke Braun, MD German Diabetes Association- Working Group Diabetes and Geriatrics
Study Chair: Thomas Kubiak, MD German Diabetes Association- Working Group Diabetes and Geriatrics
Study Chair: Ulrich A Müller, Prof University of Jena
Study Chair: Jörn Kuntsche, MD German Diabetes Association- Working Group Diabetes and Geriatrics
Study Chair: Martina Meier-Höfig, MD German Diabetes Association- Working Group Diabetes and Geriatrics
German Diabetes Association
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP