Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391040
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2006-10-20
Brief Title:
SGS a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus
Sponsor:
German Diabetes Association
Organization:
German Diabetes Association
Study Overview
Official Title:
SGS a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus - a Prospective Randomized Controlled Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None