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OpenTrials
Completed

NCT Number: NCT01914172

Health Needs of Patients With Kallmann Syndrome

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.

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Key information

Conditions

Kallmann Syndrome Congenital Abnormalities Congenital Hypogonadotropic Hypogonadism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disorder of Sex Development, 46,XY Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Hypogonadism Idiopathic Hypogonadotropic Hypogonadism Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Urogenital Abnormalities Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

online questionairres

Other

see group descriptions

Other names: patient focus groups

Primary outcomes

  1. illness perception

    Time frame: baseline

    subjective self-assessment questionnaire of how KS/CHH impacts a patient's life

  2. depression symptoms

    Time frame: baseline

    self-rated questionnaire of depression symptoms

  3. adherence to treatment

    Time frame: baseline

    self-report of adherence to medication treatment and periods without treatment or healthcare

  4. understandability and actionability of patient education materials

    Time frame: baeline

    completion of Patient Education Materials Assessment Tool (PEMAT)

Secondary outcomes

  1. coping

    Time frame: 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

  2. Interactions wth healthcare

    Time frame: baseline

    A questionnaire reporting the quality and type of interactions with healthcare providers and the healthcare system

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • University of Lausanne

Registry information

Official study title

Factors Affecting Health Promoting Behavior in Rare Disease Patients: A Mixed Methods Study of Men With Congenital Hypogonadotropic Hypogonadism (CHH)

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Aug 2, 2013
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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