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Completed

NCT Number: NCT00559078

Qualitative Research on Women With Congenital Adrenal Hyperplasia

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.

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Key information

Conditions

Congenital Adrenal Hyperplasia Adrenal Gland Diseases Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Ovotesticular Disorders of Sex Development Personal Satisfaction Psychological Well-Being Steroid Metabolism, Inborn Errors Urogenital Abnormalities Urogenital Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Hour-long, qualitative, phone interview

Primary outcomes

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

    Time frame: 1 hour

Secondary outcomes

  1. Demographic Questionnaire

    Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Lehigh University

Other

Registry information

Official study title

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

Acronym: CAH

Important dates

Study start
2007
Study completion
2009
First posted
Nov 16, 2007
Registry last updated
Nov 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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