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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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