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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01077882

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

'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 or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effectiveness of a novel educational program on the quality of life and the clinical outcome. [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.

Secondary Outcome Measures

Depression severity [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.
Lifestyle [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.
Medical consumption and cost-effectiveness evaluation [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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