Quality of LifePULNCT03324919
Patient Centered Care Situation and Health-related Quality of Life by Patients With Psoriasis, Urticaria or Lupus
An observational study of Quality of Life, run by University Hospital Regensburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- HRQL
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2016to 1 Sep 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Psoriasis, Urticaria or Lupus erythematodes. History for the respective disease with the appropriate score classification by Guideline.
Who may be able to join
- Voluntary consent by written and oral explanation.
- Patients with the diseases Psoriasis, Urticaria or Lupus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Quality of Life
- Being tested
- HRQL
- Keywords
- Psoriasis, Urticaria, Lupus erythematodes, qualtiy of life
- Medical subject headings
- Psoriasis, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRQLBehavioural
Also called one-time survey
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis, HRQL | Patients with a medical diagnosis of Psoriasis were enclosed. Receives: Behavioral: HRQL | |
| Urticaria, HRQL | Patients with a medical diagnosis of Urticaria were enclosed. Receives: Behavioral: HRQL | |
| Lupus erythematodes, HRQL | Patients with a medical diagnosis of Lupus were enclosed. Receives: Behavioral: HRQL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Mar 2016
- Primary completion30 Apr 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg
- Responsible party
- Principal investigator, Tim Maisch, University Hospital Regensburg
- Investigators
- Tim Maisch, PhD., Principal investigator, University Hospital Regensburg, Department of Dermatology, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324919
- Sponsor's protocol ID
- UHRegensburg
- Acronym
- PUL
- Status last verified
- Oct 2017
- First submitted
- 14 Mar 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23663069Kuhn 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.
PubMed 24486120Muller 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.
PubMed 25822586
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03324919
- Acronym / sponsor ID
- PUL / UHRegensburg
- Conditions
- Quality of Life
- Keywords
- Psoriasis, Urticaria, Lupus erythematodes, qualtiy of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- University of Regensburg
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriasis, HRQL | – | Behavioral: HRQLPatients with a medical diagnosis of Psoriasis were enclosed. |
| Urticaria, HRQL | – | Behavioral: HRQLPatients with a medical diagnosis of Urticaria were enclosed. |
| Lupus erythematodes, HRQL | – | Behavioral: HRQLPatients with a medical diagnosis of Lupus were enclosed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Psoriasis, Urticaria or Lupus erythematodes. History for the respective disease with the appropriate score classification by Guideline.
Key inclusion criteria (2 listed)
- Voluntary consent by written and oral explanation.
- Patients with the diseases Psoriasis, Urticaria or Lupus
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRQLAlso: one-time surveyIntervention 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. | Behavioural | Lupus erythematodes, HRQL, Psoriasis, HRQL, Urticaria, HRQL |
Primary outcome
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
2 secondary outcomes
Identification of relevant health-related quality of life parameters of these patients
Time frame: 24 months
Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Background: PubMed 23663069Bewley 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.
- Background: PubMed 24486120Kuhn 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.
- Background: PubMed 25822586Muller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Maisch, PhD. principal investigator
University Hospital Regensburg, Department of Dermatology, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University Hospital Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of patient centered care situation and health-related quality of life of patients with Psoriasis, Urtikaria and Lupus erythematosus (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324919, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.