Structured Patient Education and Quality of Life of Elderly Patients With Diabetes Mellitus- a Prospective Study

Metabolic Control Clinical Trial

Official title:

Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444483
• Other study ID #: 0099-9/98 (KIMII)-955
• Status: Completed
• Phase: N/A
• First received: March 6, 2007
• Last updated: March 6, 2007

Study information

• Verified date: March 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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, acute/late 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Gender: Both
• Age group: 54 Years and older

Eligibility

Inclusion Criteria:

• diabetes mellitus, insulin therapy, age >54 years, hyperglycemia

Exclusion Criteria:

• dementia, severe neurological deficits, polioencephalitis, rejection of informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Impact of Structured DTTP on Quality of Life
• Insulin Therapy
• Metabolic Control
• Psychological Aspects

Intervention

Behavioral:
• Structured diabetes teaching and treatment program

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	University of Jena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.
Secondary	A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy.