PsoriasisPhase 4OnderHUIDsNCT01077882
Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
A Phase 4 study testing education on skin disease conditions, Stress-reduction techniques and Lifestyle factors and psycho-education in people with Psoriasis and Atopic Dermatitis, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- education on skin disease conditions, Stress-reduction techniques and Lifestyle factors and psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
'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.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- education on skin disease conditions, Stress-reduction techniques, Lifestyle factors and psycho-education, no educational program
- Keywords
- Moderate and severe psoriasis and atopic dermatitis
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education on skin disease conditionsBehavioural
information about several skin diseases skin function recommendation on care of skin
Stress-reduction techniquesBehavioural
Physical Training yoga mindfulness-based stress reduction
Lifestyle factors and psycho-educationBehavioural
by dietician and psychiatrist
no educational programOther
standard care without educational program
| Study group | Role | What they receive |
|---|---|---|
| current therapy | Placebo comparator | Not described Receives: Other: no educational program |
| current therapy with educational program | Experimental | Not described Receives: Behavioral: education on skin disease conditions; Behavioral: Stress-reduction techniques; Behavioral: Lifestyle factors and psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 weeks, after 6 and 9 months
Secondary outcomes (3)
Depression severity
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.
Measured: At 12 weeks, 6 months and 9 months
Lifestyle
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.
Measured: At 12 weeks, 6 months and 9 months
Medical consumption and cost-effectiveness evaluation
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).
Measured: At 12 weeks, 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077882
- Sponsor's protocol ID
- 2009/691
- Acronym
- OnderHUIDs
- Status last verified
- Jul 2012
- First submitted
- 26 Feb 2010
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01077882
- Acronym / sponsor ID
- OnderHUIDs / 2009/691
- Conditions
- Psoriasis, Atopic Dermatitis
- Keywords
- Moderate and severe psoriasis and atopic dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current therapy | Placebo comparator | Other: no educational program |
| current therapy with educational program | Experimental | Behavioral: education on skin disease conditions, Behavioral: Stress-reduction techniques, Behavioral: Lifestyle factors and psycho-education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education on skin disease conditionsinformation about several skin diseases skin function recommendation on care of skin | Behavioural | current therapy with educational program |
| Stress-reduction techniquesPhysical Training yoga mindfulness-based stress reduction | Behavioural | current therapy with educational program |
| Lifestyle factors and psycho-educationby dietician and psychiatrist | Behavioural | current therapy with educational program |
| no educational programstandard care without educational program | Other | current therapy |
Primary outcome
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.
3 secondary outcomes
Depression severity
Time frame: At 12 weeks, 6 months and 9 months
Lifestyle
Time frame: At 12 weeks, 6 months and 9 months
Medical consumption and cost-effectiveness evaluation
Time frame: At 12 weeks, 6 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Lambert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing education on skin disease conditions, Stress-reduction techniques and Lifestyle factors and psycho-education in people with Psoriasis and Atopic Dermatitis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012.