Clinical trial NCT03324919: Patient Centered Care Situation and Health-related Quality of Life by Patients With Psoriasis, Urticaria or Lupus
Official title: Patient Centered Care Situation and Health-related Quality of Life of Patients From Non-urban Practice vs University Hospital With Diagnosis Psoriasis Vulgaris, Urticaria or Lupus Erythematodes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Psoriasis
Urticaria
Lupus erythematodes
qualtiy of life
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
Collaborators: name: University of Regensburg
First posted: 2017-10-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Psoriasis, Urticaria or Lupus erythematodes. History for the respective disease with the appropriate score classification by Guideline.

Brief summary: This study is based on a survey about the patient centered care situation and health-related quality of life of patients with diagnoses Psoriasis, Urtikaria or Lupus erythematodes. Detection of relevant parameters of quality of life by these patients serves for the detection of psychosocial burden of the mentioned skin diseases, thus gaining an increasing importance for prospective economic issues. This survey is a behaviorally based questionnaire for patients with the above diseases and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like.

Detailed description: The care of patients with the above indications is based on a wide variety of available therapies. This study is based on a survey about the patient centered care situation and health-related quality of life of patients with diagnoses Psoriasis, Urtikaria or Lupus erythematodes. Therefore a cross-sectional survey will be done of patients with the above diseases from non-urban practices vs. urban practices (University Hospital). An adequate diagnosis and treatment of Psorisasis, Urticaria or Lupus erythematodes is often problematic due to the diverse and complex organ manifestations. However adequate diagnosis and appropriate treatments of these diseases is often conducted by various medical specialists in both outpatient and in-patient care. Lack of access and ability of the rural population to get an appropriate therapy may lead by these patients to false diagnosis or a therapeutic oversupply of an only symptom-oriented therapy. Furthermore the partly chronic character in the above mentioned diseases with recurrent symptoms, connected with prolonged itching periods and long-lasting treatments by these patients can lead to both emotional, mental stress and physical isolation. This situation does not only affect the health but also the overall quality of life of these patients. Therefore this study addresses several factors concerning the patient's perceived health status and to detect changes or differences in health status occurring between groups (patients from non-urban practices vs urban practices)

Eligibility criteria: Inclusion Criteria:

* Voluntary consent by written and oral explanation.
* Patients with the diseases Psoriasis, Urticaria or Lupus

Exclusion Criteria:

* Children and adolescents \< 18 years
* pregnancy and breast feeding period of women
* History of abuse of alcohol, drugs or other substances, or factors that limit the ability to cooperate and compliance in the study

Primary outcomes:
measure: Investigation of patient centered care situation and health-related quality of life of patients with Psoriasis, Urtikaria and Lupus erythematosus
timeFrame: 24 months
Secondary outcomes:
measure: Identification of relevant health-related quality of life parameters of these patients
timeFrame: 24 months
measure: Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus
timeFrame: 24 months
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
Study officials:
affiliation: University Hospital Regensburg, Department of Dermatology, Germany
name: Tim Maisch, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bewley A, Burrage DM, Ersser SJ, Hansen M, Ward C. Identifying individual psychosocial and adherence support needs in patients with psoriasis: a multinational two-stage qualitative and quantitative study. J Eur Acad Dermatol Venereol. 2014 Jun;28(6):763-70. doi: 10.1111/jdv.12174. Epub 2013 May 13.
citation: Kuhn A, Landmann A. The classification and diagnosis of cutaneous lupus erythematosus. J Autoimmun. 2014 Feb-Mar;48-49:14-9. doi: 10.1016/j.jaut.2014.01.021. Epub 2014 Jan 31.
citation: Muller K, Karrer S, Apfelbacher C, Blome C, Berneburg M, Koller M. [Quality of life in dermatology. From measurement to practical implementation]. Hautarzt. 2015 Apr;66(4):287-96; quiz 297-8. doi: 10.1007/s00105-015-3599-8. German.