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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

February 26, 2010
July 4, 2012
January 2010
April 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01077882 on ClinicalTrials.gov Archive Site
  • 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).
  • To analyze the cost reduction of OnderHUIDs from a pharmaco-economic perspective [ Time Frame: at 12 weeks and after 9 months ] [ Designated as safety issue: No ]
    The costs include the activities of physicians, nurses and other health care providers, as well as material and accommodation. Possible savings relate to reduced need for medication, and reduced visits related to the management of the disease (post the 12 week program). Therefore a questionnaire about medical consumption will be completed monthly from the beginning of the program on and 9 months thereafter
  • assessment of work productivity and absenteeism [ Time Frame: until 9 months after the programme ] [ Designated as safety issue: No ]
    Furthermore, information related to work productivity and absenteeism will be collected, using the 'Vragenlijst over Ziekte en Werk' (Hakkaart and Elsink-Bot, 1999) monthly from the beginning of the program on and 9 months thereafter.
  • cost-effectiveness ratio from a societal perspective [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To analyze the cost-effectiveness ratio of OnderHUIDs from a societal perspective, whereby cost is defined as the net cost of the program (investment costs minus potential savings) and effectiveness will be expressed in quality adjusted life years. Modelling approaches will be applied to translate the possible 6 month effects on generic quality of life into possible long term QALY gains.
Not Provided
Not Provided
 
Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
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' 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Psoriasis
  • Atopic Dermatitis
  • 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
  • Other: no educational program
    standard care without educational program
  • Placebo Comparator: current therapy
    Intervention: Other: no educational program
  • Experimental: current therapy with educational program
    Interventions:
    • Behavioral: education on skin disease conditions
    • Behavioral: Stress-reduction techniques
    • Behavioral: Lifestyle factors and psycho-education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01077882
2009/691
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Jo Lambert, MD, PhD University Hospital, Ghent
University Hospital, Ghent
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP