NCT00559078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

First QC Date

November 15, 2007

Last Update Submit

November 6, 2009

Conditions

Congenital Adrenal Hyperplasia

Keywords

Adrenal Hyperplasia, CongenitalPsychosexual DevelopmentSexual DevelopmentIntersexQualitativeCAHInterviewDisorder of Sex DevelopmentTelephoneQuality of LifeMental HealthCounseling

Outcome Measures

Primary Outcomes (1)

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

    1 hour

Secondary Outcomes (1)

  • Demographic Questionnaire

    15 minutes

Study Arms (1)

CAH

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

Other: Interview

Interventions

InterviewOTHER

Hour-long, qualitative, phone interview

CAH

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States

You may qualify if:

  • XX, 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

You may not qualify if:

  • Non-classical or late-onset CAH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Adrenal Hyperplasia, CongenitalOvotesticular Disorders of Sex DevelopmentDisorders of Sex DevelopmentPsychological Well-Being

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Adrenogenital SyndromeUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAdrenal Gland DiseasesEndocrine System DiseasesGonadal DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Matthew A Malouf, BA

    Lehigh University Counseling Psychology

    STUDY DIRECTOR

  • Arpana G Inman

    Lehigh University Counseling Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

July 1, 2007

Study Completion

May 1, 2009

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

US(1)