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NCT Number: NCT00444483

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

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.

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Key information

Conditions

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

Age range

54 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Structured diabetes teaching and treatment program

Behavioral

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • University of Jena

Registry information

Official study title

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

Important dates

First posted
Mar 7, 2007
Registry last updated
Mar 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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