Health Needs of Patients With Kallmann Syndrome

Kallmann Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914172
• Other study ID #: 233/13
• Secondary ID: 233/13
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: September 27, 2017
• Start date: July 2013
• Est. completion date: September 27, 2017

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: September 27, 2017
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hypogonadotropic Hypogonadism
• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism
• Kallmann Syndrome
• Rare Diseases
• Syndrome

Intervention

Other:
• online questionairres
see group descriptions

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University of Lausanne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

COST Action BM1105, Badiu C, Bonomi M, Borshchevsky I, Cools M, Craen M, Ghervan C, Hauschild M, Hershkovitz E, Hrabovszky E, Juul A, Kim SH, Kumanov P, Lecumberri B, Lemos MC, Neocleous V, Niedziela M, Djurdjevic SP, Persani L, Phan-Hug F, Pignatelli D, — View Citation

Dwyer AA, Quinton R, Morin D, Pitteloud N. Identifying the unmet health needs of patients with congenital hypogonadotropic hypogonadism using a web-based needs assessment: implications for online interventions and peer-to-peer support. Orphanet J Rare Dis — View Citation

Dwyer AA, Quinton R, Pitteloud N, Morin D. Psychosexual development in men with congenital hypogonadotropic hypogonadism on long-term treatment: a mixed methods study. Sex Med. 2015 Mar;3(1):32-41. doi: 10.1002/sm2.50. — View Citation

Dwyer AA, Tiemensma J, Quinton R, Pitteloud N, Morin D. Adherence to treatment in men with hypogonadotrophic hypogonadism. Clin Endocrinol (Oxf). 2017 Mar;86(3):377-383. doi: 10.1111/cen.13236. Epub 2017 Jan 11. — View Citation

Dzemaili S, Tiemensma J, Quinton R, Pitteloud N, Morin D, Dwyer AA. Beyond hormone replacement: quality of life in women with congenital hypogonadotropic hypogonadism. Endocr Connect. 2017 Aug;6(6):404-412. doi: 10.1530/EC-17-0095. Epub 2017 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	illness perception	subjective self-assessment questionnaire of how KS/CHH impacts a patient's life	baseline
Primary	depression symptoms	self-rated questionnaire of depression symptoms	baseline
Primary	adherence to treatment	self-report of adherence to medication treatment and periods without treatment or healthcare	baseline
Primary	understandability and actionability of patient education materials	completion of Patient Education Materials Assessment Tool (PEMAT)	baeline
Secondary	coping	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	baseline
Secondary	Interactions wth healthcare	A questionnaire reporting the quality and type of interactions with healthcare providers and the healthcare system	baseline