Prevalence and Subjective Impairment of Quality of Life (QoL) Due to Dermatologic Diseases in Internal Medicine Patients
| Tracking Information | |||||
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| First Received Date ICMJE | January 6, 2010 | ||||
| Last Updated Date | January 10, 2011 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01044043 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence and Subjective Impairment of Quality of Life (QoL) Due to Dermatologic Diseases in Internal Medicine Patients | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This is a 3 months single centre clinical patient-oriented study to evaluate the prevalence and impairment in QOL of dermatologic diseases in patients hospitalised in internal medicine. Up to 200 patients hospitalised at the division of internal medicine for any reason are going to be offered participation by a patient information form given to patients at the time of admission, as well as oral information about the study. Written informed consent will be obtained by the investigators after patients have had adequate time to consider their participation in the study. Participating patients will be examined clinically for dermatologic pathologies at a single visit. In the case of signs of dermatologic disease, investigators are going to recommend further diagnostic procedures to the physician in charge and/or the referring physician, depending on the urgency of the suspected diagnosis. This procedure is meant to avoid giving referring physicians the impression that active patient acquisition for the department of Dermatology is an aim of this study. Diagnostic procedures that are performed upon suspicion of a specific dermatologic disease at the Division of Internal Medicine are going to be performed during the hospitalisation period. All other diagnostic or operative procedures are going to be advised to the referring physician. Study participants are going to be interviewed by the investigators about impairment in QOL of their illnesses. Two separate questionnaires are going to be filled in by each participant. For measurement of general QOL, the widely used SF-12 questionnaire (8 questions) is going to be used. To measure specific impairment in QOL by dermatologic disease, participants are going to be asked to fill in the DLQI (Dermatology life quality index, 10 questions). Photographic documentation of specific identified lesions will be made and pictures stored exclusively in the secured electronic patient file (KISIM). Medication and all identified diseases will be noted. All diagnostically useful information is going to be recorded in the patient file and transmitted to the referring physician in the discharge letter. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Prevalance and subjective inpairment of quality of life due to dermatologic deseases in internal medicine patients |
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| Condition ICMJE | Dermatologic Disease of Inpatients in Internal Medicine | ||||
| Intervention ICMJE | Procedure: clinical examination and quality of life questionnaire
clinical examination and quality of life questionnaire |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: Patients will be eligible for enrolment if they fulfil the following criteria:
Exclusion criteria: Patients will be excluded from the study if they fulfill any of the following criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01044043 | ||||
| Other Study ID Numbers ICMJE | PREV_DERM_INTMED | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital Zurich, Edouard Battegay, Switzerland: University of Zurich | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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