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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: SGS education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus - a Prospective Randomized Controlled Multicenter Trial

Resource links provided by NLM:


Further study details as provided by German Diabetes Association:

Primary Outcome Measures:
  • HbA1c decrease, reduction of hypoglycemia, acute complications

Secondary Outcome Measures:
  • treatment satisfaction, ability for diabetes management, diabetes knowledge

Estimated Enrollment: 200
Study Start Date: November 2003
Estimated Study Completion Date: May 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391040

Locations
Germany
Bethesda Hospital
Stuttgart, Baden Württemberg, Germany, 70184
Sponsors and Collaborators
German Diabetes Association
Menarini Group
Deutsche Diabtesstiftung, Germany
Investigators
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00391040     History of Changes
Other Study ID Numbers: 1201-10/03
Study First Received: October 20, 2006
Last Updated: October 20, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Association:
diabetes mellitus, structured treatment and teaching, education,
elderly patients, geriatrics

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014