Clinical trial NCT01044043: Prevalence and Subjective Impairment of Quality of Life (QoL) Due to Dermatologic Diseases in Internal Medicine Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatologic Disease of Inpatients in Internal Medicine
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prevalance and subjective inpairment of quality of life due to dermatologic deseases in internal medicine patients

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.


Eligibility criteria: Inclusion criteria: Patients will be eligible for enrolment if they fulfil the following criteria:

1. Male or female patients, age ? 18 years of age and
2. Hospitalised at the Division of Internal Medicine, University Hospital Zurich
3. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2).

Exclusion criteria: Patients will be excluded from the study if they fulfill any of the following criteria:

1. Ability to communicate orally severely impaired due to any reason, namely illness or inability to speak German.
2. Terminal patients or other patients where participation in a visit with oral and physical examination would represent an unreasonable exertion.
3. Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References: