NCT03481218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

29 days

First QC Date

March 13, 2018

Last Update Submit

April 12, 2018

Conditions

Type 1 DiabetesQuality of Life

Keywords

Type 1 diabetesQuality of lifePersonality traitsYoung adults

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Differences in quality of life based on gender

    15 minutes

  • Differences in quality of life based on glycaemic control

    15 minutes

Study Arms (2)

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) -BREFOther: The Satisfaction With Life Scale - SWLSOther: Big Five Inventory - BFI; John in Srivastava, 1999

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) -BREFOther: The Satisfaction With Life Scale - SWLS

Interventions

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.

Individuals without chronic diseasesPatients with type 1 diabetes
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.

Individuals without chronic diseasesPatients with type 1 diabetes
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.

Patients with type 1 diabetes

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital Ljubljana

Ljubljana, Slovenija/Osrednja Regija, 1000, Slovenia

Location

University of Ljubljana, Faculty of Arts, Department of psychology

Ljubljana, Slovenija/Osrednja Regija, 1000, Slovenia

Location

Related Publications (16)

  • 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.

    PMID: 26396503BACKGROUND

  • 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.

    PMID: 7965560BACKGROUND

  • 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.

    PMID: 23182614BACKGROUND

  • 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.

    PMID: 22361221BACKGROUND

  • 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.

    PMID: 10977026BACKGROUND

  • 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.

    PMID: 26861574BACKGROUND

  • 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.

    PMID: 28143733BACKGROUND

  • 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.

    PMID: 24582483BACKGROUND

  • 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.

    PMID: 27662040BACKGROUND

  • 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.

    PMID: 24439690BACKGROUND

  • 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.

    PMID: 24496583BACKGROUND

  • 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.

    PMID: 19592356BACKGROUND

  • 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.

    PMID: 27663096BACKGROUND

  • 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.

    PMID: 28081448BACKGROUND

  • 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.

    PMID: 23466181BACKGROUND

  • 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.

    PMID: 22512523BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 29, 2018

Study Start

January 30, 2018

Primary Completion

February 28, 2018

Study Completion

April 5, 2018

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

SL(2)