Life Quality and Health in Patients With Klinefelter Syndrome

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690013
• Other study ID #: 2012-41-0666
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: May 31, 2015
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: July 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

For the Klinefelter group:

Inclusion Criteria:

• Verified Klinefelter syndrome

Exclusion Criteria:

For the control group:

Inclusion Criteria:

• age-,educational,and residence-matched

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease
• Klinefelter Syndrome
• Mental Disorders
• Physical Disorders
• Psychotic Disorders
• Quality of Life
• Syndrome

Locations

Country	Name	City	State
Denmark	Medical Department M, Aarhus Universityhospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Housing		3 month	No
Other	Fatherhood		3 month	No
Other	School and educational	Information about school and education	3 month	No
Other	Income		3 month	No
Other	Attachment to the labor	working position, working hour, period of sick leave	3 month	No
Other	Marital status		3 month	No
Other	Medication		3 month	No
Other	Chronic disease		3 month	No
Primary	Quality of life	Quality of life score is measured with the WHOQOL-Brief questionnaire	3 month	No
Primary	Satisfaction with life	Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale	3 month	No
Primary	ADHD symptoms	ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist	3 month	No
Primary	General health	General health is measured by SF-36 questionnaire	3 month	No
Primary	Erectile function	Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.	3 month	No