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Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis (OnderHUIDs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01077882
First received: February 26, 2010
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.


Condition Intervention Phase
Psoriasis
Atopic Dermatitis
Behavioral: education on skin disease conditions
Behavioral: Stress-reduction techniques
Behavioral: Lifestyle factors and psycho-education
Other: no educational program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Effectiveness of a novel educational program on the quality of life and the clinical outcome. [ Time Frame: At 12 weeks, after 6 and 9 months ] [ Designated as safety issue: No ]

    Therefore quality of life questionnaires are completed at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months. The quality of life questionnaires are Daily life quality index, Skindex 29, EuroQol -5D, Short Form - 36 , Psoriasis disability index, Quality of Life Index for Atopic Dermatitis.

    The clinical effectiveness is determined by measuring psoriasis area and severity index (PASI) or scoring atopic dermatitis (SCORAD) at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months.



Secondary Outcome Measures:
  • Depression severity [ Time Frame: At 12 weeks, 6 months and 9 months ] [ Designated as safety issue: No ]
    Beck Depression Inventory (BDI) is a self-completed questionnaire with 21 questions. It is one of the most widely used instruments for measuring depression severity. BDI scores are collected during the four study visits.

  • Lifestyle [ Time Frame: At 12 weeks, 6 months and 9 months ] [ Designated as safety issue: No ]
    Patients are queried for changes in smoking behaviour and physical activity monthly. Also, stress is examined during the four study visits,therefore we use the Everyday Problem Checklist.

  • Medical consumption and cost-effectiveness evaluation [ Time Frame: At 12 weeks, 6 months and 9 months ] [ Designated as safety issue: No ]
    Medical therapy of patients is divided into: topical therapy, systemic therapy, combination of topical and systemic therapy or no therapy. Patients are asked for changes in medical therapy monthly. Also, medical consumption is followed: costs for medication and doctor visits related to the management of the skin disease. EuroQol-5D (EQ-5D) questionnaires are used as standardised instrument to measure health outcomes. For cost-utility analysis, gain in quality-adjusted life years utilities is plotted against time, using the area under the curve approach (cost in EUR/EQ-5D gain).


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: current therapy Other: no educational program
standard care without educational program
Experimental: current therapy with educational program Behavioral: education on skin disease conditions
information about several skin diseases skin function recommendation on care of skin
Behavioral: Stress-reduction techniques
Physical Training yoga mindfulness-based stress reduction
Behavioral: Lifestyle factors and psycho-education
by dietician and psychiatrist

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have given written informed consent
  • Women or men of any race
  • Patients who are 18-75 years of age
  • Diagnosis of psoriasis or atopic dermatitis

Exclusion Criteria:

  • Patients with a cognitive disorder (not able to understand, speak, read or write..)
  • Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months
  • Patients under experimental pharmaceutical medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077882

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Jo Lambert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01077882     History of Changes
Other Study ID Numbers: 2009/691
Study First Received: February 26, 2010
Last Updated: July 4, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Moderate and severe psoriasis and atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Psoriasis
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014