NCT01077882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

February 26, 2010

Last Update Submit

July 4, 2012

Conditions

PsoriasisAtopic Dermatitis

Keywords

Moderate and severe psoriasis and atopic dermatitis

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (3)

  • Depression severity

    At 12 weeks, 6 months and 9 months

  • Lifestyle

    At 12 weeks, 6 months and 9 months

  • Medical consumption and cost-effectiveness evaluation

    At 12 weeks, 6 months and 9 months

Study Arms (2)

current therapy

PLACEBO COMPARATOR
Other: no educational program

current therapy with educational program

EXPERIMENTAL
Behavioral: education on skin disease conditionsBehavioral: Stress-reduction techniquesBehavioral: Lifestyle factors and psycho-education

Interventions

education on skin disease conditionsBEHAVIORAL

information about several skin diseases skin function recommendation on care of skin

current therapy with educational program
Stress-reduction techniquesBEHAVIORAL

Physical Training yoga mindfulness-based stress reduction

current therapy with educational program
Lifestyle factors and psycho-educationBEHAVIORAL

by dietician and psychiatrist

current therapy with educational program
no educational programOTHER

standard care without educational program

current therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicLymphoma, Follicular

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Study Officials

  • Jo Lambert, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

BE(1)