AsthmaNCT04216680
Asthma and Intimate Partner Violence
An observational study of Asthma and Domestic Violence, run by National Jewish Health at 1 site in United States.
Trial summary
This is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Asthma, Domestic Violence
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 2 Jan 2021
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult asthmatics ages 18-69 years who are able to participate in a questionnaire-based study.
Who may be able to join
- Diagnosis of asthma as defined as postbronchodilator response of at least 12% and 200 milliliters improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity and/or evidence of positive airway hyperresponsiveness.
Who cannot join
- Medical factors that would preclude participation as determined by the investigators. Examples include blindness, mental illness that grossly impairs judgment, or active injury requiring treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Eileen Wang, 303-270-2796, wange@njhealth.org
About this study
This is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder.
- Conditions
- Asthma, Domestic Violence
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test
asthma control scored on scale of 0-25 with higher numbers reflecting better control.
Measured: last 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start2 Jan 2020 (estimated)
- Primary completion2 Jan 2021 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Wang, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216680
- Sponsor's protocol ID
- HS-3068
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT04216680
- Acronym / sponsor ID
- HS-3068
- Conditions
- Asthma, Domestic Violence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 2 Jan 2020 (estimated)
- Primary completion
- 2 Jan 2021 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 3 Jan 2020 (actual)
- 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 is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult asthmatics ages 18-69 years who are able to participate in a questionnaire-based study.
Key inclusion criteria (1 listed)
- Diagnosis of asthma as defined as postbronchodilator response of at least 12% and 200 milliliters improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity and/or evidence of positive airway hyperresponsiveness.
Key exclusion criteria (1 listed)
- Medical factors that would preclude participation as determined by the investigators. Examples include blindness, mental illness that grossly impairs judgment, or active injury requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma Control Test
Time frame: last 30 days
asthma control scored on scale of 0-25 with higher numbers reflecting better control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
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 Asthma and Domestic Violence, run by National Jewish Health 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 1 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: status not confirmed, as of the sponsor's last update on 6 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen Wang, MD, MPH (303-270-2796, WANGE@NJHEALTH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (time frame: last 30 days). 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 6 Jan 2020.