Diabetes Mellitus Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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