SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00391040|
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : October 23, 2006
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Behavioral: SGS education|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus - a Prospective Randomized Controlled Multicenter Trial|
|Study Start Date :||November 2003|
|Estimated Study Completion Date :||May 2006|
- HbA1c decrease, reduction of hypoglycemia, acute complications
- treatment satisfaction, ability for diabetes management, diabetes knowledge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391040
|Stuttgart, Baden Württemberg, Germany, 70184|
|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|