NCT03324919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 14, 2016

Last Update Submit

October 24, 2017

Conditions

Quality of Life

Keywords

PsoriasisUrticariaLupus erythematodesqualtiy of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Identification of relevant health-related quality of life parameters of these patients

    24 months

  • Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus

    24 months

Study Arms (3)

Psoriasis, HRQL

Patients with a medical diagnosis of Psoriasis were enclosed.

Behavioral: HRQL

Urticaria, HRQL

Patients with a medical diagnosis of Urticaria were enclosed.

Behavioral: HRQL

Lupus erythematodes, HRQL

Patients with a medical diagnosis of Lupus were enclosed.

Behavioral: HRQL

Interventions

HRQLBEHAVIORAL

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.

Also known as: one-time survey
Lupus erythematodes, HRQLPsoriasis, HRQLUrticaria, HRQL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Psoriasis, Urticaria or Lupus erythematodes. History for the respective disease with the appropriate score classification by Guideline.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related 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.

    PMID: 23663069BACKGROUND

  • 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.

    PMID: 24486120BACKGROUND

  • 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.

    PMID: 25822586BACKGROUND

MeSH Terms

Conditions

PsoriasisUrticaria

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tim Maisch, PhD.

    University Hospital Regensburg, Department of Dermatology, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

March 14, 2016

First Posted

October 30, 2017

Study Start

March 1, 2016

Primary Completion

April 30, 2017

Study Completion

September 1, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)