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

NCT ID: NCT00391040

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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diabetes mellitus, structured treatment and teaching, education, elderly patients, geriatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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SGS education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menarini Group

INDUSTRY

Sponsor Role collaborator

Deutsche Diabtesstiftung, Germany

UNKNOWN

Sponsor Role collaborator

German Diabetes Association

OTHER

Sponsor Role lead

Principal Investigators

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Andrej Zeyfang, MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Association- Working Group Diabetes and Geriatrics

Anke Braun, MD

Role: STUDY_CHAIR

German Diabetes Association- Working Group Diabetes and Geriatrics

Thomas Kubiak, MD

Role: STUDY_CHAIR

German Diabetes Association- Working Group Diabetes and Geriatrics

Ulrich A Müller, Prof

Role: STUDY_CHAIR

University of Jena

Jörn Kuntsche, MD

Role: STUDY_CHAIR

German Diabetes Association- Working Group Diabetes and Geriatrics

Martina Meier-Höfig, MD

Role: STUDY_CHAIR

German Diabetes Association- Working Group Diabetes and Geriatrics

Locations

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Bethesda Hospital

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Zeyfang A. [Diabetes in old age -- do we overstrain our patients?]. Dtsch Med Wochenschr. 2006 May 19;131(20):1159-62. doi: 10.1055/s-2006-941744. No abstract available. German.

Reference Type BACKGROUND
PMID: 16705538 (View on PubMed)

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

Reference Type RESULT
PMID: 16035489 (View on PubMed)

Related Links

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http://www.diabetes-im-alter.de

a randomized controlled trial to proof effectiveness of a structured treatment and teaching programme for elderly patients with diabetes mellitus

Other Identifiers

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1201-10/03

Identifier Type: -

Identifier Source: org_study_id