Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444483
Status:
COMPLETED
Last Update Posted:
2007-03-07
First Post:
2007-03-06
Brief Title:
Structured Patient Education and Quality of Life of Elderly Patients With Diabetes Mellitus- a Prospective Study
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2007-03
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:
The improvement of the quality of life QoL is one of the key treatment goals in patients with diabetes mellitus Objective Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated elderly patients with type 2 diabetes mellitus Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic therapy were successively recruited and participated in the structured inpatient diabetes treatment and teaching program DTTP for insulin therapy QoL was assessed before and six months after participation in the DTTP with the standardised questionnaire of Lohr analysing the subscales social relations physical complaints worries about the future diet restrictions fear of hypoglycemia and daily struggles
Detailed Description:
All patients with type 2 diabetes mellitus who were older than 54 years and admitted by general practitioner to the inpatient unit of the university hospital of Jena Germany for participation in a structured DTTP for insulin therapy because of hyperglycemia were candidates for successive inclusion in the study All patients participated in a five day inpatient structured DTTP for single or split dose administration of intermediate-acting insulin which included instruction in insulin injection self- monitoring hypoglycemia acutelate complications nutrition and foot care Quality of life was assessed by using a validated instrument the standardised QoL- questionnaire of Lohr et al 21 both before and six months after participation in the DTTP This questionnaire consists of 58 Likert- scaled items comprising the subscales social relations physical complaints worries about the future diet restrictions fear of hypoglycemia and daily struggles Higher scores reflect higher quality of life with 100 as an optimum quality of life The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP
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