Qualitative Research on Women With Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia Clinical Trial

— CAH  

Official title:

Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: Congenital Adrenal Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559078
• Other study ID #: 1-Malouf
• Status: Completed
• Phase: N/A
• First received: November 15, 2007
• Last updated: November 6, 2009
• Start date: July 2007
• Est. completion date: May 2009

Study information

• Verified date: November 2009
• Source: Lehigh University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This qualitative interview-based study will investigate the impact that living with congenital adrenal hyperplasia has for women in the following areas: health-related quality of life (HRQL), psychological health, and health-seeking behaviors.

Description:

Congenital Adrenal Hyperplasia is a chronic-illness requiring life-long treatment and is caused by an inherited enzyme deficiency that leads to an overproduction of hormones produced by the adrenal glands, which in turn, masculinizes the female genitalia before birth. While the mechanisms by which CAH influences physiological development are understood, the impact of this hormonal elevation on health-related quality of life (HRQL), psychological health, and health-seeking behaviors is less clear. This study is guided by three research questions: (1) how does CAH influence HRQL domains (physical, functional, emotional and interpersonally), (2) how does CAH influence the mental health of women diagnosed with CAH, and (3) how does CAH influence decisions to seek help from a counselor? Semi-structured qualitative interviews will be conducted with women with CAH. Interviews will be analyzed through the Consensual Qualitative Research (CQR) methodology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• 46XX, Females

• Diagnosed by a physician with CAH (either simple-virilizing or salt-losing types)

• Willing to complete a brief demographic questionnaire and participate in an hour long telephone interview

Exclusion Criteria:

• Non-classical or late-onset CAH

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

Other:
• Interview
Hour-long, qualitative, phone interview

Locations

Country	Name	City	State
United States	Lehigh University	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lehigh University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support		1 hour	No
Secondary	Demographic Questionnaire		15 minutes	No