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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481218
• Other study ID #: MN-2017
• Status: Completed
• First received: March 13, 2018
• Last updated: April 12, 2018
• Start date: January 30, 2018
• Est. completion date: April 5, 2018

Study information

• Verified date: April 2018
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: April 5, 2018
• Est. primary completion date: February 28, 2018
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Quality of Life
• Type 1 Diabetes

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Slovenia	University Children's Hospital Ljubljana	Ljubljana	Slovenija/Osrednja Regija
Slovenia	University of Ljubljana, Faculty of Arts, Department of psychology	Ljubljana	Slovenija/Osrednja Regija

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

References & Publications (16)

Alvarado-Martel D, Velasco R, Sánchez-Hernández RM, Carrillo A, Nóvoa FJ, Wägner AM. Quality of life and type 1 diabetes: a study assessing patients' perceptions and self-management needs. Patient Prefer Adherence. 2015 Sep 14;9:1315-23. doi: 10.2147/PPA.S87310. eCollection 2015. — View Citation

Booth-Kewley S, Vickers RR Jr. Associations between major domains of personality and health behavior. J Pers. 1994 Sep;62(3):281-98. — View Citation

Hilliard ME, Mann KA, Peugh JL, Hood KK. How poorer quality of life in adolescence predicts subsequent type 1 diabetes management and control. Patient Educ Couns. 2013 Apr;91(1):120-5. doi: 10.1016/j.pec.2012.10.014. Epub 2012 Nov 22. — View Citation

Lane JD, McCaskill CC, Williams PG, Parekh PI, Feinglos MN, Surwit RS. Personality correlates of glycemic control in type 2 diabetes. Diabetes Care. 2000 Sep;23(9):1321-5. — View Citation

Lawrence JM, Yi-Frazier JP, Black MH, Anderson A, Hood K, Imperatore G, Klingensmith GJ, Naughton M, Mayer-Davis EJ, Seid M; SEARCH for Diabetes in Youth Study Group. Demographic and clinical correlates of diabetes-related quality of life among youth with type 1 diabetes. J Pediatr. 2012 Aug;161(2):201-7.e2. doi: 10.1016/j.jpeds.2012.01.016. Epub 2012 Feb 22. — View Citation

Majumder E, Cogen FR, Monaghan M. Self-Management Strategies in Emerging Adults With Type 1 Diabetes. J Pediatr Health Care. 2017 Jan - Feb;31(1):29-36. doi: 10.1016/j.pedhc.2016.01.003. Epub 2016 Feb 6. — View Citation

Martyn-Nemeth P, Quinn L, Penckofer S, Park C, Hofer V, Burke L. Fear of hypoglycemia: Influence on glycemic variability and self-management behavior in young adults with type 1 diabetes. J Diabetes Complications. 2017 Apr;31(4):735-741. doi: 10.1016/j.jdiacomp.2016.12.015. Epub 2017 Jan 20. — View Citation

Naughton MJ, Yi-Frazier JP, Morgan TM, Seid M, Lawrence JM, Klingensmith GJ, Waitzfelder B, Standiford DA, Loots B; SEARCH for Diabetes in Youth Study Group. Longitudinal associations between sex, diabetes self-care, and health-related quality of life among youth with type 1 or type 2 diabetes mellitus. J Pediatr. 2014 Jun;164(6):1376-83.e1. doi: 10.1016/j.jpeds.2014.01.027. Epub 2014 Feb 26. — View Citation

Nielsen HB, Ovesen LL, Mortensen LH, Lau CJ, Joensen LE. Type 1 diabetes, quality of life, occupational status and education level - A comparative population-based study. Diabetes Res Clin Pract. 2016 Nov;121:62-68. doi: 10.1016/j.diabres.2016.08.021. Epub 2016 Sep 8. — View Citation

Rassart J, Luyckx K, Klimstra TA, Moons P, Groven C, Weets I. Personality and illness adaptation in adults with type 1 diabetes: the intervening role of illness coping and perceptions. J Clin Psychol Med Settings. 2014 Mar;21(1):41-55. doi: 10.1007/s10880-014-9387-2. — View Citation

Rassart J, Luyckx K, Moons P, Weets I. Personality and self-esteem in emerging adults with Type 1 diabetes. J Psychosom Res. 2014 Feb;76(2):139-45. doi: 10.1016/j.jpsychores.2013.11.015. Epub 2013 Dec 6. — View Citation

Raynor DA, Levine H. Associations between the five-factor model of personality and health behaviors among college students. J Am Coll Health. 2009 Jul-Aug;58(1):73-81. doi: 10.3200/JACH.58.1.73-82. — View Citation

Rechenberg K, Whittemore R, Grey M. Anxiety in Youth With Type 1 Diabetes. J Pediatr Nurs. 2017 Jan - Feb;32:64-71. doi: 10.1016/j.pedn.2016.08.007. Epub 2016 Sep 20. Review. — View Citation

Strandberg RB, Graue M, Wentzel-Larsen T, Peyrot M, Wahl AK, Rokne B. The relationships among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being in Norwegian adults with Type 1 diabetes. Diabetes Res Clin Pract. 2017 Feb;124:11-19. doi: 10.1016/j.diabres.2016.12.018. Epub 2016 Dec 27. — View Citation

Trento M, Panero F, Porta M, Gruden G, Barutta F, Cerutti F, Gambino R, Perotto M, Cavallo Perin P, Bruno G; Piedmont Study Group for Diabetes Epidemiology. Diabetes-specific variables associated with quality of life changes in young diabetic people: the type 1 diabetes Registry of Turin (Italy). Nutr Metab Cardiovasc Dis. 2013 Oct;23(10):1031-6. doi: 10.1016/j.numecd.2013.01.004. Epub 2013 Mar 7. — View Citation

Wheeler K, Wagaman A, McCord D. Personality traits as predictors of adherence in adolescents with type I diabetes. J Child Adolesc Psychiatr Nurs. 2012 May;25(2):66-74. doi: 10.1111/j.1744-6171.2012.00329.x. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in quality of life	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).	15 minutes
Primary	Personality traits associated with diabetes management	Which personality traits are associated with good and poor diabetes management. Personality traits will be measured with The Big Five Inventory questionnaire.	15 minutes
Secondary	Differences in quality of life based on gender	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).	15 minutes
Secondary	Differences in quality of life based on glycaemic control	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).	15 minutes