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

This study has been completed.
Sponsor:
Collaborator:
University of Jena
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00444483
First received: March 6, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention
Impact of Structured DTTP on Quality of Life
Insulin Therapy
Metabolic Control
Psychological Aspects
Behavioral: Structured diabetes teaching and treatment program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.

Secondary Outcome Measures:
  • A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy.

Estimated Enrollment: 50
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.

  Eligibility

Ages Eligible for Study:   54 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • dementia, severe neurological deficits, polioencephalitis, rejection of informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00444483

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444483     History of Changes
Other Study ID Numbers: 0099-9/98 (KIMII)-955
Study First Received: March 6, 2007
Last Updated: March 6, 2007
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 16, 2014