Health-Related Quality of Life Assessment And Communication During 48 Weeks of Treatment of Moderate to Severe Psoriasis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24504

Enrollment

200

Registered

2008-07-01

Start date

2008-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keywords: Psoriasis, Health-Related Quality of Life, Etanercept. doctor-patient communication, psoriasis patients

Interventions

Standardized HRQL-assessment and HRQL-communication in dermatological practice. Prior to each consultation HRQL will be assessed on desk-top pc at the treatment centre. During each consultation, HRQL-

Eligibility

Inclusion criteria

Inclusion criteria: 1. Eighteen years of age or older at time of consent. 2. Established diagnosis of plaque psoriasis. 3. Meeting the Dutch reimbursement criteria for etanercept: ▪ PASI > 10, or PASI > 8 with Skindex-29 score > 35. ▪ Ineffective or contra-indications to PUVA treatment twice weekly for 10 weeks. ▪ Ineffective or contra-indications to treatment with cyclosporine 3-5 mg/kg/day for 16 weeks. ▪ Ineffective or contra-indications to treatment with MTX 22,5 mg/day for 16 weeks. 4. Naive to treatment with etanercept.

Exclusion criteria

Exclusion criteria: 1. Patients of childbearing potential who are not using or willing to use adequate anti-conceptive measures. 2. Contraindications for the use of etanercept: sepsis or risk of sepsis, including local infections. 3. Previous anti-TNF treatment. 4 .Patients who are mentally and/or physically not able to complete the study questionnaire(s). 5. Patients who insufficiently speak the Dutch language to fully understand and complete the study questionnaire(s). 6. Patients who are not willing or not able to discuss HRQL-issues.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoints: 1. Communication (COM): Communication Questionnaire (COM), a study-specific two-dimensional questionnaire concerning a) the quantity of HRQL-communication during consultations b) the satisfaction with doctor ¨C patient communication. 2. Overall HRQL: Dermatology Life Quality Index, a well-established dermatology-specific HRQL measure (DLQI).	—

Secondary

Measure	Time frame
Secondary Efficacy Endpoints: 1. Health Status (HS) Medical Outcomes Study 36-item Short-Form General Health Survey, a well-established, eight-dimensional, generic health status measure (SF-36). 2. Global Disease Severity (GDS) a. Psoriasis Area and Severity Index (PASI) b. Physician Global Assessment & Patient Global Assessment. 3. Overall Evaluation (OE) A study-specific questionnaire concerning a) satisfaction with the treatment process, including doctor ¨C patient communication b) satisfaction with treatment outcomes c) the feasibility of HRQL-assessment and HRQL- communication in dermatological practice at large.	—

Measure

Time frame

Secondary Efficacy Endpoints: 1. Health Status (HS) Medical Outcomes Study 36-item Short-Form General Health Survey, a well-established, eight-dimensional, generic health status measure (SF-36). 2. Global Disease Severity (GDS) a. Psoriasis Area and Severity Index (PASI) b. Physician Global Assessment & Patient Global Assessment. 3. Overall Evaluation (OE) A study-specific questionnaire concerning a) satisfaction with the treatment process, including doctor ¨C patient communication b) satisfaction with treatment outcomes c) the feasibility of HRQL-assessment and HRQL- communication in dermatological practice at large.

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Contacts

Public ContactC.A.C. Prinsen

Postbus 22660

c.a.prinsen@amc.uva.nl+31 (0)20 5662757

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)