PsoriasisNCT05056168
Validation of a Dermatology-Specific Treatment Satisfaction Instrument
An observational study of Psoriasis, run by University of Southern California at 1 site in United States.
Trial summary
The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Dermatology-Specific Treatment Satisfaction Instrument
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2021to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥ 18 years) dermatology patients with psoriasis from LAC+USC and Keck Medical Centers, the Brigham and Women's Hospital, and the Mount Sinai Hospital.
Who may be able to join
- Adult (≥ 18 years)
- Psoriasis patients undergoing some form of treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.
- Conditions
- Psoriasis
- Being tested
- Dermatology-Specific Treatment Satisfaction Instrument
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatology-Specific Treatment Satisfaction InstrumentOther
Study subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients' preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis
For this survey study, the investigators will gather descriptive statistics for each item in the questionnaire. The investigators will also measure the following psychometric properties: measurement error, reliability and construct validity, as measured by convergent and known-groups validity
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start13 Nov 2021
- Primary completion14 Mar 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Armstrong, University of Southern California
- Investigators
- April Armstrong, MD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056168
- Sponsor's protocol ID
- HS-18-00891-AM004
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2021
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Dermatology-Specific Treatment Satisfaction Instrument
- ClinicalTrials.gov ID
- NCT05056168
- Acronym / sponsor ID
- HS-18-00891-AM004
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Brigham and Women's Hospital
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Sep 2021 (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.
The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥ 18 years) dermatology patients with psoriasis from LAC+USC and Keck Medical Centers, the Brigham and Women's Hospital, and the Mount Sinai Hospital.
Key inclusion criteria (2 listed)
- Adult (≥ 18 years)
- Psoriasis patients undergoing some form of treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dermatology-Specific Treatment Satisfaction InstrumentStudy subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients' preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms. | Other | – |
Primary outcome
Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis
Time frame: 8 months
For this survey study, the investigators will gather descriptive statistics for each item in the questionnaire. The investigators will also measure the following psychometric properties: measurement error, reliability and construct validity, as measured by convergent and known-groups validity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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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.
April Armstrong, MD, MPH principal investigator
University of Southern California
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 Psoriasis, run by University of Southern California 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 2 inclusion and 0 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 15 Nov 2023. 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?
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?
Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis (time frame: 8 months). 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 15 Nov 2023.