Life Quality and Health in Patients With Klinefelter Syndrome

Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey

Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1 in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter syndrome have psychological complaints and physical discomfort. Some patients report a positive effect of testosterone treatment, whereas others do not.

The aim of this study is:

(i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate functional, physical and mental health in patients with Klinefelter syndrome.

Questionnaire concerning mental and physical health and life quality are sent out to patients with KS and to age-, educational- and zipcode-matched men from the general population. The questionnaire include questions about housing, income, marital status, fatherhood, medication, chronic disease,school and education, attachment to the labor, sexual and erectile function, life quality, mental and physical health, satisfaction with life and symptoms of attention deficits hyperactivity disorders.

Study Overview

• Status: Completed
• Conditions: Mental Disorders; Quality of Life; Klinefelter Syndrome; Physical Disorders

• Study Type: Observational
• Enrollment (Actual): 452

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Medical Department M, Aarhus Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Klinefelter patients is recruited from endocrinology, genetics and fertility clinics in Denmark.

An age-, educational, and zipcode-matched control group was created from Statistics Denmark by extracting five randomly selected men for each KS subject

Description

For the Klinefelter group:

Inclusion Criteria:

• Verified Klinefelter syndrome

Exclusion Criteria:

• none

For the control group:

Inclusion Criteria:

• age-,educational,and residence-matched

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Klinefelter; Men with Klinefelter syndrome
Control; Men from the general population, matched by age, education and zipcode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life score is measured with the WHOQOL-Brief questionnaire	3 month
Satisfaction with life	Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale	3 month
ADHD symptoms	ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist	3 month
General health	General health is measured by SF-36 questionnaire	3 month
Erectile function	Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.	3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Housing		3 month
Fatherhood		3 month
School and educational	Information about school and education	3 month
Income		3 month
Attachment to the labor	working position, working hour, period of sick leave	3 month
Marital status		3 month
Medication		3 month
Chronic disease		3 month

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Claus H Gravholt, MD, Dr.med., Medical Department M, Aarhus Universityhospital, Aarhus

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Chromosome Disorders; Sex Chromosome Disorders; Sex Chromosome Disorders of Sex Development; Hypogonadism; Syndrome; Disease; Mental Disorders; Klinefelter Syndrome
• Other Study ID Numbers: 2012-41-0666