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

March 6, 2007 updated by: Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 6, 2007

First Posted (Estimate)

March 7, 2007

Study Record Updates

Last Update Posted (Estimate)

March 7, 2007

Last Update Submitted That Met QC Criteria

March 6, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0099-9/98 (KIMII)-955

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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