CAH: Qualitative Research on Women With Congenital Adrenal Hyperplasia

Sponsor

Lehigh University (Other)

Overall Status

Completed

CT.gov ID

NCT00559078

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Adrenal Hyperplasia	Other: Interview

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

16 participants

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
CAH Women diagnosed with CAH (either simple virilizing or salt-losing)	Other: Interview Hour-long, qualitative, phone interview

Arm

Intervention/Treatment

CAH

Women diagnosed with CAH (either simple virilizing or salt-losing)

Other: Interview

Hour-long, qualitative, phone interview

Outcome Measures

Primary Outcome Measures

Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support [1 hour]

Secondary Outcome Measures

Demographic Questionnaire [15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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