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Health Needs of Patients With Kallmann Syndrome

NCT ID: NCT01914172

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-09-27

Brief Summary

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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

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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

Conditions

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Kallmann Syndrome Congenital Hypogonadotropic Hypogonadism Idiopathic Hypogonadotropic Hypogonadism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Online web-based questionnaire

Up to 200 patients with KS/CHH will be recruited to complete an online web-based questionnaire (less than 30 minutes to complete)

online questionairres

Intervention Type OTHER

see group descriptions

Patient focus group

Focus groups (90-120 minutes in duration) with 6-12 patients. Up to 36 patients total

No interventions assigned to this group

Online web-based evaluation of patient education materials

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)

online questionairres

Intervention Type OTHER

see group descriptions

Interventions

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online questionairres

see group descriptions

Intervention Type OTHER

Other Intervention Names

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patient focus groups

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Andrew Dwyer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Dwyer, PhD, FNP-BC

Role: PRINCIPAL_INVESTIGATOR

Centre Hositalier Universitaire Vaudois (CHUV)

Locations

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Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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. 2014 Jun 11;9:83. doi: 10.1186/1750-1172-9-83.

Reference Type RESULT
PMID: 24915927 (View on PubMed)

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.

Reference Type RESULT
PMID: 25844173 (View on PubMed)

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.

Reference Type RESULT
PMID: 27647266 (View on PubMed)

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.

Reference Type RESULT
PMID: 28698240 (View on PubMed)

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, Pitteloud N, Popovic V, Quinton R, Skordis N, Smith N, Stefanija MA, Xu C, Young J, Dwyer AA. Developing and evaluating rare disease educational materials co-created by expert clinicians and patients: the paradigm of congenital hypogonadotropic hypogonadism. Orphanet J Rare Dis. 2017 Mar 20;12(1):57. doi: 10.1186/s13023-017-0608-2.

Reference Type RESULT
PMID: 28320476 (View on PubMed)

Other Identifiers

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233/13

Identifier Type: OTHER

Identifier Source: secondary_id

233/13

Identifier Type: -

Identifier Source: org_study_id