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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT00444483
Collaborator
University of Jena (Other)
50

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Structured diabetes teaching and treatment program
N/A

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, 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.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcome Measures

  1. The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP. []

Secondary Outcome Measures

  1. A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
54 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • diabetes mellitus, insulin therapy, age >54 years, hyperglycemia
Exclusion Criteria:
  • dementia, severe neurological deficits, polioencephalitis, rejection of informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Heidelberg University
  • University of Jena

Investigators

  • Principal Investigator: Ulrich Müller, MD, University of Jena
  • Study Chair: Anke Braun, MD, Bethanien Hospital Heidelberg, Germany
  • Study Chair: Ralf Schiel, MD, Inselklinik Heringsdorf, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00444483
Other Study ID Numbers:
  • 0099-9/98 (KIMII)-955
First Posted:
Mar 7, 2007
Last Update Posted:
Mar 7, 2007
Last Verified:
Mar 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2007