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NCT00391040 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00391040
Other study ID # 1201-10/03
Secondary ID
Status Completed
Phase N/A
First received October 20, 2006
Last updated October 20, 2006
Start date November 2003
Est. completion date May 2006

Study information
Verified date October 2006
Source German Diabetes Association
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• SGS education

Locations
Country Name City State
Germany Bethesda Hospital Stuttgart Baden Württemberg

Sponsors (3)
Lead Sponsor Collaborator
German Diabetes Association Deutsche Diabtesstiftung, Germany, Menarini Group

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Zeyfang A. [Diabetes in old age -- do we overstrain our patients?]. Dtsch Med Wochenschr. 2006 May 19;131(20):1159-62. German. — View Citation

Zeyfang A. [Structured educational programs for geriatric patients with diabetes mellitus]. MMW Fortschr Med. 2005 Jun 30;147(26):43, 45-6. German. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c decrease, reduction of hypoglycemia, acute complications
Secondary treatment satisfaction, ability for diabetes management, diabetes knowledge
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