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Type 1 DiabetesNCT03481218

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

An observational study of Type 1 Diabetes and Quality of Life, run by University of Ljubljana, Faculty of Medicine at 2 sites in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Type 1 Diabetes, Quality of Life
What is being tested?
The World Health Organization Quality of Life (WHOQOL) -BREF, The Satisfaction With Life Scale - SWLS and Big Five Inventory - BFI; John in Srivastava, 1999
How many people
238 participants
Where
2 sitesSlovenia
Study dates
30 Jan 2018to 5 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Adult

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.

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Slovenia2 sites

  • University Children's Hospital Ljubljana

    Ljubljana, Slovenija/Osrednja Regija, 1000

  • University of Ljubljana, Faculty of Arts, Department of psychology

    Ljubljana, Slovenija/Osrednja Regija, 1000

Other trials in Slovenia

About this study

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.

Read the 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.

Being tested
The World Health Organization Quality of Life (WHOQOL) -BREF, The Satisfaction With Life Scale - SWLS, Big Five Inventory - BFI; John in Srivastava, 1999
Keywords
Type 1 diabetes, Quality of life, Personality traits, Young adults
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The World Health Organization Quality of Life (WHOQOL) -BREFOther

    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 - SWLSOther

    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, 1999Other

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

Study groups in NCT03481218
Study groupRoleWhat they receive
Patients with type 1 diabetesYoung adults (male and female) between the ages of 18 and 35, who have type 1 diabetes for at least one year.
Receives: 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
Individuals without chronic diseasesYoung adults (male and female) between the ages of 18 and 35, without chronic diseases.
Receives: Other: The World Health Organization Quality of Life (WHOQOL) -BREF; Other: The Satisfaction With Life Scale - SWLS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 15 minutes

  2. 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.

    Measured: 15 minutes

Secondary outcomes (2)

  1. 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).

    Measured: 15 minutes

  2. 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).

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start30 Jan 2018
  3. Primary completion28 Feb 2018
  4. Study completion5 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03481218
Sponsor's protocol ID
MN-2017
Status last verified
Apr 2018
First submitted
13 Mar 2018
Last updated
13 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alvarado-Martel D, Velasco R, Sanchez-Hernandez RM, Carrillo A, Novoa FJ, Wagner 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.

    PubMed 26396503

  • Booth-Kewley S, Vickers RR Jr. Associations between major domains of personality and health behavior. J Pers. 1994 Sep;62(3):281-98. doi: 10.1111/j.1467-6494.1994.tb00298.x.

    PubMed 7965560

  • 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.

    PubMed 23182614

  • 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.

    PubMed 22361221

  • 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. doi: 10.2337/diacare.23.9.1321.

    PubMed 10977026

  • 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.

    PubMed 26861574

  • 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.

    PubMed 28143733

  • 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.

    PubMed 24582483

  • 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.

    PubMed 27662040

  • 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.

    PubMed 24439690

  • 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.

    PubMed 24496583

  • 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.

    PubMed 19592356

  • 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.

    PubMed 27663096

  • 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.

    PubMed 28081448

  • 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.

    PubMed 23466181

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes and Quality of Life, run by University of Ljubljana, Faculty of Medicine at 2 sites in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in quality of life (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03481218, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.

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