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

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ClinicalTrials.gov Identifier: NCT03324919
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
University of Regensburg
Information provided by (Responsible Party):
Tim Maisch, University Hospital Regensburg

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.

Condition or disease Intervention/treatment
Quality of Life Behavioral: HRQL

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)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 220 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Psoriasis, HRQL
Patients with a medical diagnosis of Psoriasis were enclosed.
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.
Other Name: one-time survey

Urticaria, HRQL
Patients with a medical diagnosis of Urticaria were enclosed.
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.
Other Name: one-time survey

Lupus erythematodes, HRQL
Patients with a medical diagnosis of Lupus were enclosed.
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.
Other Name: one-time survey




Primary Outcome Measures :
  1. Investigation of patient centered care situation and health-related quality of life of patients with Psoriasis, Urtikaria and Lupus erythematosus [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Identification of relevant health-related quality of life parameters of these patients [ Time Frame: 24 months ]
    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.

  2. Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus [ Time Frame: 24 months ]
    EQ5D-5L Questionnaire and vas score, depending on the travel maximal distance accessing healthcare



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324919


Locations
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Germany
University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
University Hospital Regensburg
University of Regensburg
Investigators
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Principal Investigator: Tim Maisch, PhD. University Hospital Regensburg, Department of Dermatology, Germany

Additional Information:

Publications:
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Responsible Party: Tim Maisch, PD Dr., University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT03324919     History of Changes
Other Study ID Numbers: UHRegensburg
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tim Maisch, University Hospital Regensburg:
Psoriasis
Urticaria
Lupus erythematodes
qualtiy of life

Additional relevant MeSH terms:
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Psoriasis
Urticaria
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Vascular
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases