Open Uncontrolled Validation Study for the German Version of the Actinic Keratosis Quality of Life Questionnaire (AKQoL)

NCT02325661 | Completed

• 1 other identifier: KEK-ZH-Nr. 2014-0252
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes per patient

Study Arms (1)

cognitive interviewing

OTHER

individual cognitive interviewing, 30 minutes per patient

Other: cognitive interviewing

Interventions

cognitive interviewing OTHER

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.

cognitive interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of informed consent

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22962980 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Günther Hofbauer, Prof.Dr.med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 25, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

CH (1)