Patient Centered Care Situation and Health-related Quality of Life by Patients With Psoriasis, Urticaria or Lupus

Quality of Life Clinical Trial

— PUL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324919
• Other study ID #: UHRegensburg
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: October 24, 2017
• Start date: March 1, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: October 2017
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 1, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Quality of Life
• Urticaria

Intervention

Behavioral:
• HRQL
Intervention of patient centered care situation and health-related quality of life of patients with Psoriasis, Urticaria or Lupus erythematodes from non-urban practices vs urban practises. Identification of relevant health-related quality of life parameters of these patients.

Locations

Country	Name	City	State
Germany	University Hospital Regensburg	Regensburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Regensburg	University of Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. Review. — View Citation

Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of patient centered care situation and health-related quality of life of patients with Psoriasis, Urtikaria and Lupus erythematosus	Detection of the quality of life score by these patients. Questionnaire administration and clinical documentation takes place when patients were present at the outpatient clinic of the Department of Dermatology, University Hospital Regensburg. Key inclusion criteria: diagnoses of psoriasis, urticaria or lupus erythematodes	24 months
Secondary	Identification of relevant health-related quality of life parameters of these patients	Questionnaire, that my medical care situation must be improved at all depending on my DLQI score. The DLQI-Questionnaire will be used.The questionnaires address skin-specific aspects as well as general aspects (activities of daily living, overall health-status) of quality of life.	24 months
Secondary	Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus	EQ5D-5L Questionnaire and vas score, depending on the travel maximal distance accessing healthcare	24 months