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NCT Number: NCT03481218

Quality of Life and Personality Traits in Patients With Type 1 Diabetes

The aims of this study are to examine the differences in the quality of life among individuals with type 1 diabetes and individuals without chronic diseases, differences in the quality of life among men and women with type 1 diabetes and the differences in the quality of life among individuals with good and poor glycaemic control. The relationship between personality traits and the management of disease in patients with type 1 diabetes will also be examined.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Ljubljana, Ljubljana, Slovenija/Osrednja Regija, Slovenia

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About this study

Diabetes affects the daily life of patients, chronic diseases have a major impact on the quality of life of individuals. Chronic illness affects family life of an individual, his professional life, as well as leisure activities, chronic illness can also increase worries, fears, feelings of sadness and helplessness.

Past studies examining the quality of life construct in patients with type 1 diabetes (T1D) showed that patients achieved lower levels of life quality, compared to individuals without T1D. Studies show that women with T1D achieve lower scores on the quality of life scales than men with T1D and differences in gender are already present in adolescence.

Patients with poor glycaemic control achieve lower results on the quality of life scales, the effect of hemoglobin on the quality of life is direct, as well as indirect.

The studies in which they examined the attitudes of personality traits with diabetes management show that two personality traits are associated with the management of the disease, the successful management of the disease is primarily associated with the conscientiousness. Concerning the effect of neuroticism on the management of the disease, research results are contradictory.

Who can participate

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

Inclusion criteria

  • Age between 18 and 35
  • Diagnosed with Type 1 diabetes for at least one year (for the T1D group)
  • Willing to participate in study

Exclusion criteria

-

Treatment and study plan

The World Health Organization Quality of Life (WHOQOL) -BREF

Other

The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

The Satisfaction With Life Scale - SWLS

Other

The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.

Big Five Inventory - BFI; John in Srivastava, 1999

Other

The Big Five Inventory (BFI) is a self-report inventory designed to measure the Big Five dimensions.

Primary outcomes

  1. Differences in quality of life

    Time frame: 15 minutes

    Differences in quality of life in patients with T1D and individuals without chronic diseases. Quality of life will be measured with the WHOQOL-BREF quality of life assessment tool (questionnaire).

  2. Personality traits associated with diabetes management

    Time frame: 15 minutes

    Which personality traits are associated with good and poor diabetes management. Personality traits will be measured with The Big Five Inventory questionnaire.

Secondary outcomes

  1. Differences in quality of life based on gender

    Time frame: 15 minutes

    Differences in quality of life between men and women with T1D. Quality of life will be measured with the WHOQOL-BREF quality of life assessment tool (questionnaire).

  2. Differences in quality of life based on glycaemic control

    Time frame: 15 minutes

    Differences in quality of life between patients with good and bad glycaemic control. Quality of life will be measured with the WHOQOL-BREF quality of life assessment tool (questionnaire). Glycaemic control will be reported from participants (HbA1c).

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Apr 13, 2018

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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