Actinic KeratosisAKQOLVSNCT02325661
Open Uncontrolled Validation Study for the German Version of the Actinic Keratosis Quality of Life Questionnaire (AKQoL)
A study testing cognitive interviewing in people with Actinic Keratosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to translate the "AKQoL"-questionnaire which measures the quality of life of patients with actinic keratosis into German and to validate it for the Swiss population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- cognitive interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- Patients with actinic keratosis of the department of Dermatology, University Hospital Zurich
- Male and Female subjects > 18 years of age
- Good understanding of written and spoken German
- Sufficient physical and mental capacity to comprehend the questions
- Written informed consent by the participant
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to translate the "AKQoL"-questionnaire which measures the quality of life of patients with actinic keratosis into German and to validate it for the Swiss population.
By using the technique of cognitive interviewing the investigators are focussing on the patients' understanding of the questions. The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions according to the feedback of the patients. The revised version will then be presented to a new population.
Read the detailed description
Actinic keratosis is a UV-induced skin disease, which presents as a reddish, squamous and sometimes itchy lesion. Actinic keratosis seems to have a negative impact on patients' quality of life. Esmann et al. elaborated on patients with actinic keratosis from Zealand, Denmark a questionnaire which measures the quality of life.
The objective of this study is to translate this questionnaire into German and to validate it for the Swiss population. This questionnaire might become part of a planned national register for data collection of patients with AK.
The investigators will assess the content validity of the questionnaire by using the technique of cognitive interviewing. The investigators are going to talk 34 patients with AK from the department of Dermatology, University Hospital Zurich through the translated version. Thereby, the investigators are focusing on the patients' understanding of the questions.
The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions in the sense that they become more clear and are understood by different interviewee in the same way. The revised version will then be presented to a new population. The performance of cognitive interview sessions and revisions will continue until the survey will be approved by at least 80% of the respondents.
- Conditions
- Actinic Keratosis
- Being tested
- cognitive interviewing
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive interviewingOther
For the individual cognitive interviews we are using the two techniques "to think aloud" and the "verbal probing". "To think aloud" means, that the patients are asked to express precisely what comes to their mind when reading the single questions. This means, the interviewer is interested in the line of thoughts, which arise when reading the question. Thereby, the problems which appear in the usually covert process of answering a question should be revealed. In a second step, we are using the "verbal probing" technique to identify possible misunderstandings of the questions or difficulties with single phrases. The interviewer asks further questions that target the patients' interpretation.
| Study group | Role | What they receive |
|---|---|---|
| cognitive interviewing | Other | individual cognitive interviewing, 30 minutes per patient Receives: Other: cognitive interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intersubject agreement on validation of the questions of the AKQoL
Consistent answers by study participants on cognitive debriefing. This is a qualitative, not a quantitative measure.
Measured: 30 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Günther Hofbauer, Prof.Dr.med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325661
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0252
- Acronym
- AKQOLVS
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Esmann S, Vinding GR, Christensen KB, Jemec GB. Assessing the influence of actinic keratosis on patients' quality of life: the AKQoL questionnaire. Br J Dermatol. 2013 Feb;168(2):277-83. doi: 10.1111/bjd.12036.
PubMed 22962980
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Uncontrolled Validation Study for the German Version of the Actinic Keratosis Quality of Life Questionnaire (AKQoL)
- ClinicalTrials.gov ID
- NCT02325661
- Acronym / sponsor ID
- AKQOLVS / KEK-ZH-Nr. 2014-0252
- Conditions
- Actinic Keratosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Dec 2014 (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.
The objective of this study is to translate the "AKQoL"-questionnaire which measures the quality of life of patients with actinic keratosis into German and to validate it for the Swiss population.
By using the technique of cognitive interviewing the investigators are focussing on the patients' understanding of the questions. The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions according to the feedback of the patients. The revised version will then be presented to a new population.
Detailed description
Actinic keratosis is a UV-induced skin disease, which presents as a reddish, squamous and sometimes itchy lesion. Actinic keratosis seems to have a negative impact on patients' quality of life. Esmann et al. elaborated on patients with actinic keratosis from Zealand, Denmark a questionnaire which measures the quality of life.
The objective of this study is to translate this questionnaire into German and to validate it for the Swiss population. This questionnaire might become part of a planned national register for data collection of patients with AK.
The investigators will assess the content validity of the questionnaire by using the technique of cognitive interviewing. The investigators are going to talk 34 patients with AK from the department of Dermatology, University Hospital Zurich through the translated version. Thereby, the investigators are focusing on the patients' understanding of the questions.
The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions in the sense that they become more clear and are understood by different interviewee in the same way. The revised version will then be presented to a new population. The performance of cognitive interview sessions and revisions will continue until the survey will be approved by at least 80% of the respondents.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive interviewing | Other | Other: cognitive interviewingindividual cognitive interviewing, 30 minutes per patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with actinic keratosis of the department of Dermatology, University Hospital Zurich
- Male and Female subjects > 18 years of age
- Good understanding of written and spoken German
- Sufficient physical and mental capacity to comprehend the questions
- Written informed consent by the participant
Key exclusion criteria (1 listed)
- Lack of informed consent
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 |
|---|---|---|
| cognitive interviewingFor the individual cognitive interviews we are using the two techniques "to think aloud" and the "verbal probing". "To think aloud" means, that the patients are asked to express precisely what comes to their mind when reading the single questions. This means, the interviewer is interested in the line of thoughts, which arise when reading the question. Thereby, the problems which appear in the usually covert process of answering a question should be revealed. In a second step, we are using the "verbal probing" technique to identify possible misunderstandings of the questions or difficulties with single phrases. The interviewer asks further questions that target the patients' interpretation. | Other | cognitive interviewing |
Primary outcome
Intersubject agreement on validation of the questions of the AKQoL
Time frame: 30 minutes per patient
Consistent answers by study participants on cognitive debriefing. This is a qualitative, not a quantitative measure.
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 25 Dec 2014.
- Background: PubMed 22962980Esmann S, Vinding GR, Christensen KB, Jemec GB. Assessing the influence of actinic keratosis on patients' quality of life: the AKQoL questionnaire. Br J Dermatol. 2013 Feb;168(2):277-83. doi: 10.1111/bjd.12036.
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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.
Günther Hofbauer, Prof.Dr.med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive interviewing in people with Actinic Keratosis, run by University of Zurich at 1 site in Switzerland.
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 5 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 25 Dec 2014. 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 Switzerland. 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?
Intersubject agreement on validation of the questions of the AKQoL (time frame: 30 minutes per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325661, which also lists 1 linked publication.
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 25 Dec 2014.