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

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ClinicalTrials.gov Identifier: NCT03481218
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Quality of Life Other: The World Health Organization Quality of Life (WHOQOL) -BREF Other: The Satisfaction With Life Scale - SWLS Other: Big Five Inventory - BFI; John in Srivastava, 1999

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 238 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Quality of Life and Personality Traits in Patients With Type 1 Diabetes
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with type 1 diabetes
Young adults (male and female) between the ages of 18 and 35, who have type 1 diabetes for at least one year.
Other: The World Health Organization Quality of Life (WHOQOL) -BREF
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

Other: The Satisfaction With Life Scale - SWLS
The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.

Other: Big Five Inventory - BFI; John in Srivastava, 1999
The Big Five Inventory (BFI) is a self-report inventory designed to measure the Big Five dimensions.

Individuals without chronic diseases
Young adults (male and female) between the ages of 18 and 35, without chronic diseases.
Other: The World Health Organization Quality of Life (WHOQOL) -BREF
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

Other: The Satisfaction With Life Scale - SWLS
The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Young adults of 18 to 35 years of age with type 1 diabetes and young adults of 18 to 35 years of age without chronic diseases.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481218


Locations
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Slovenia
University Children's Hospital Ljubljana
Ljubljana, Slovenija/Osrednja Regija, Slovenia, 1000
University of Ljubljana, Faculty of Arts, Department of psychology
Ljubljana, Slovenija/Osrednja Regija, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine

Publications:

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Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT03481218     History of Changes
Other Study ID Numbers: MN-2017
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Ljubljana, Faculty of Medicine:
Type 1 diabetes
Quality of life
Personality traits
Young adults

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases