Congenital Adrenal HyperplasiaCAHNCT00559078
Qualitative Research on Women With Congenital Adrenal Hyperplasia
An observational study of Congenital Adrenal Hyperplasia, run by Lehigh University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Interview
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States
Who may be able to join
- 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
Who cannot join
- Non-classical or late-onset CAH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: 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.
Read the 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.
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Interview
- Keywords
- Adrenal Hyperplasia, Congenital, Psychosexual Development, Sexual Development, Intersex, Qualitative, CAH, Interview, Disorder of Sex Development, Telephone, Quality of Life, Mental Health, Counseling
- Medical subject headings
- Adrenal Hyperplasia, Congenital, Ovotesticular Disorders of Sex Development, Disorders of Sex Development, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Hour-long, qualitative, phone interview
| Study group | Role | What they receive |
|---|---|---|
| CAH | Women diagnosed with CAH (either simple virilizing or salt-losing) Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support
Measured: 1 hour
Secondary outcomes (1)
Demographic Questionnaire
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startJul 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lehigh University
- Sponsor type
- University, hospital or other
- Investigators
- Matthew A Malouf, BA, Study director, Lehigh University Counseling PsychologyArpana G Inman, Principal investigator, Lehigh University Counseling Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559078
- Sponsor's protocol ID
- 1-Malouf
- Acronym
- CAH
- Status last verified
- Nov 2009
- First submitted
- 15 Nov 2007
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT00559078
- Acronym / sponsor ID
- CAH / 1-Malouf
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Adrenal Hyperplasia, Congenital, Psychosexual Development, Sexual Development, Intersex, Qualitative, CAH, Interview, Disorder of Sex Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Lehigh UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- May 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAH | – | Other: InterviewWomen diagnosed with CAH (either simple virilizing or salt-losing) |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Non-classical or late-onset CAH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewHour-long, qualitative, phone interview | Other | CAH |
Primary outcome
Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support
Time frame: 1 hour
1 secondary outcome
Demographic Questionnaire
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.
Related trials for Congenital Adrenal Hyperplasia
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingPhase 3
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A Malouf, BA study director
Lehigh University Counseling Psychology
Arpana G Inman principal investigator
Lehigh University Counseling Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Adrenal Hyperplasia, run by Lehigh University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2009.