Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017318

Trial Description

start of 1:1-Block title

Title

Analyzing the Value of an Educational Program for Psoriasis Patients: A Prospective Controlled Pilot Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A prospective controlled pilot study analyzing the beneficial effects an educational program has for psoriasis patients regarding disease activity, quality of life, mental health and patient compliance.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background: Psoriasis is a chronic inflammatory skin disease associated with a reduced quality of life. Severe disease forms put the patients at risk for life-treating cardiovascular events, metabolic, and other immune-mediated disorders. Psoriasis patients are often not sufficiently informed about their conditionleading to suboptimal treatment adherence and, consequently, worse patient outcome. We investigated the value of an educational program on knowledge and self-expertise about the disease in psoriasis patients in general and dependent on age and disease duration.
Methods: Regular visit patients who have psoriasis were asked to participate and choose to receive an additional educational program or not. Participating patients (n=53) filled out two questionnaires: one at study inclusion and one at the next regular visit or after the absolved educational program. Surveys included disease knowledge assessment and numeric rating scales (0-10) for self-expertise about the disease, therapy adherence, and therapy satisfaction. The Dermatology Life Quality Index (DLQI) was used to investigate the quality of life.
All continuous parameters were examined for statistically significant differences by paired t-test or unpaired t-test. Continuous parameters without Gaussian distribution were analyzed with the Wilcoxon matched pairs test or the Mann-Whitney test. For all categorical parameters, Fisher’s exact test was used.
Results: Patients who chose to be educated (n=24) showed a significant increase in knowledge, self-expertise about the disease and amelioration of general health. No positive short-term effects were seen on the quality of life and therapy adherence. Analyzing the effect of age and disease duration, the educational program led to significant improvement of the emotional well-being in older patients (50 years) and with a longer disease duration as well as significant amelioration of the self-expertise about psoriasis in younger patients (<50 years).
Conclusions: Patients who chose to participate in an educational program show a higher gain in knowledge and self-expertise about the psoriatic disease than patients choosing the standard regular visit. Educational program thus might have a positive effect on the long-term management of psoriasis. Further prospective long-term studies are needed to provide evidence for the influence educational programs have on outcome, quality of life, and treatment adherence of psoriatic patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017318
  •   2019/10/09
  •   [---]*
  •   yes
  •   Approved
  •   2016-597N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   L40 -  Psoriasis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   intervention group receiving an educational program

    Training group: the educational training took place twice after the patients were included in the study. The educational program treated the following topics: etiology, pathogenesis, therapy, comorbidity, nutrition, exercise and addiction in psoriasis patients.
  •   control group
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. To determine the impact of patient education for patients with psoriasis on the health-related quality of life and mental health of patients with moderate-grade psoriasis using the Dermatology Life Quality Index (DLQI), 36-item Short Form Survey (SF-36), and Hospital Anxiety and Depression Scale (HADS).

2. To determine the impact of patient education for patients with psoriasis on subjective therapy compliance, treatment satisfaction, and subjective self-assessment of disease management in patients with moderate-grade psoriasis using visual analogue scales (VAS).

Measurements were made 1-4 weeks before the first educational training and immediately after the 2nd educational training in patients assigned to the intervention group. In patients of the control group, the measure was taken immediately after inclusion in the study and 3 months thereafter.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1. To analyze the impact of patient education for patients with psoriasis on disease severity, itching and pain using the Psoriasis Area and Severity Index (PASI) and Visual Analogue Scales (VAS) for itching and pain.

2. Analysis of the impact of patient education for patients with psoriasis on psoriasis knowledge based on a questionnaire.

3. Evaluation of the training by the patients using a free text and multiple choice questions.

Measurements were made 1-4 weeks before the first educational training and immediately after the 2nd educational training in patients assigned to the intervention group. In patients of the control group, the measure was taken immediately after inclusion in the study and 3 months thereafter.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/09/19
  •   65
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusion criteria were age ≥18 years, physician-confirmed diagnosis of psoriasis (independent of disease-severity and gender), and the ability to provide informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Exclusion criteria were the inability to understand and read German.
Written informed consent was obtained from all patients willing to participate in the study.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Dermatologie, Universitätsmedizin Mannheim
    • Ms.  Prof.  Astrid  Schmieder 
    • T. Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Dermatologie, Universitätsmedizin Mannheim
    • Ms.  Prof.  Astrid  Schmieder 
    • T. Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Dermatologie, Universitätsmedizin Mannheim
    • Ms.  Prof.  Astrid  Schmieder 
    • T. Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Dermatologie, Universitätsmedizin Mannheim
    • Ms.  Prof.  Astrid  Schmieder 
    • T. Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/09/19
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.