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)

July 4, 2012 updated by: University Hospital, Ghent
'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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
At 12 weeks, after 6 and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression severity
Time Frame: At 12 weeks, 6 months and 9 months
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.
At 12 weeks, 6 months and 9 months
Lifestyle
Time Frame: At 12 weeks, 6 months and 9 months
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.
At 12 weeks, 6 months and 9 months
Medical consumption and cost-effectiveness evaluation
Time Frame: At 12 weeks, 6 months and 9 months
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).
At 12 weeks, 6 months and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Jo Lambert, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 4, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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