Health Needs of Patients With Kallmann Syndrome

Completed

• Conditions: Congenital Hypogonadotropic Hypogonadism; Kallmann Syndrome; Idiopathic Hypogonadotropic Hypogonadism
• Interventions: Other: online questionairres

• Registration Number: NCT01914172
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a rare endocrine disorder that is characterized by failure to undergo puberty combined with infertility. KS/CHH patients face a number of psychosocial burdens related to delays in diagnosis, inadequate access to expert care, and lack of information about the condition. As such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This study aims to identify the needs of patients and understand the issues that must be overcome to achieve improved health and quality of life.

Detailed Description

This study aims to examine the experiences of patients diagnosed with Kallmann syndrome (KS)/congenital hypogonadotropic hypogonadism (CHH).

The study includes two parts:

* online survey (less than 30 minutes to complete)

* focus groups with KS/CHH patients

The aim of this project is to better understand what health needs are not presently being met for these patients and to identify targets for improving the care of patients diagnosed with KS/CHH

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2014-03
• Status Verified: 2017-09
• Study Completion: 2017-09-27
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Diagnosed with congenital hypogonadotropic hypogonadism: i.e. Kallmann syndrome or idiopathic hypogonadotropic hypogonadism
• Primary language is English/capable of responding to a written questionnaire in English
• Consenting to participate in the study

Exclusion Criteria

• other diagnosis of hypogonadism: i.e. hypergonadotropic hypogonadism (Klinefelter syndrome), adult onset hypogonadism, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Online web-based questionnaire	online questionairres	Up to 200 patients with KS/CHH will be recruited to complete an online web-based questionnaire (less than 30 minutes to complete)
Online web-based evaluation of patient education materials	online questionairres	Up to 100 patients with KS/CHH will be recruited to complete an online web-based questionnaire to evaluate patient education materials (less than 15 minutes to complete)

Primary Outcome Measures

Name	Time	Method
understandability and actionability of patient education materials	baeline	completion of Patient Education Materials Assessment Tool (PEMAT)
illness perception	baseline	subjective self-assessment questionnaire of how KS/CHH impacts a patient's life
adherence to treatment	baseline	self-report of adherence to medication treatment and periods without treatment or healthcare
depression symptoms	baseline	self-rated questionnaire of depression symptoms

Secondary Outcome Measures

Name	Time	Method
coping	baseline	Focus groups will be conducted to evaluate how KS/CHH impacts patients quality of life, the barriers to better health/quality of life, and how patients cope with living with KS/CHH
Interactions wth healthcare	baseline	A questionnaire reporting the quality and type of interactions with healthcare providers and the healthcare system

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Vaud, Switzerland