Development and Feasibility of a Nurse-led Person-centered Education Program

NCT05715190 | Completed DMC

• 1 other identifier: Psoriasis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background Psoriasis is a chronic inflammatory skin disease causing reduced quality of life. Psoriasis patients are often insufficiently informed about their disease with its treatment possibilities leading to non-adherence of treatment resulting in unsatisfactory patient outcomes. We therefore propose to develop an educational intervention for psoriasis patients; evaluate the feasibility of implementing it in a nurse-led psoriasis-outpatient clinic and compare the psoriasis percentage reduction, quality of life, health literacy and patient benefit, between patients receiving this educational intervention and those receiving standard care. Method/Design We first will develop an evidence-based educational intervention in collaboration with an expert panel and second will conduct a quasi experimental feasibility study in a psoriasis outpatient clinic in Western Switzerland. Twenty four eligible patients with psoriasis will receive a multidisciplinary education, for 6 weeks. Data will be analyzed using R conducting linear models allowing us to assess the impact of the intervention on psoriasis reduction and other secondary outcomes of interest, once controlled for reliable socio-economic cofounding factors. Discussion This trial will investigate the feasibility of the elaborated nurse-led education and the planed randomized controlled trial. In this study, we will elaborate and provide an informational brochure with information concerning psoriasis in addition to a nurse-led oral educational program in addition to medical standard care. We expect that this nurse-led person-centered intervention will contribute to enhanced education with a higher functioning, better self-efficacy and improved quality of life, better disease knowledge with a better adherence to the medication protocol. The results will further inform the final design of a subsequent large-scale randomized controlled trial, which will examine the effectiveness of this educational intervention. Additionally, through this study the role of the nursing profession and its research will be strengthened in assuring that the voice of individuals, families and communities are incorporated into design and operations of clinical health systems by eliminating gaps and disparities in health care.

Conditions

Self-Management; Behavior; Patient Empowerment

Keywords

patient education; self management; behavior change

Outcome Measures

Primary Outcomes (1)

• percentage reduction of psoriasi

  percentage reduction of psoriasis using the PASI (Psoriasis Area and Severity Index) score. The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4).

  6 weeks

Secondary Outcomes (7)

• Health Literacy

  6 weeks

• Patient benefit

  6 weeks

• Life Quality Index

  6 weeks

• Psoriasis severity

  6 weeks

• Medication knowledge

  6 weeks

Study Arms (1)

nurse-led education

OTHER

Other: Education

Interventions

Education OTHER

Visiting the medical psoriasis outpatient clinic. Receiving a medical consultation, phototherapy and methotrexate treatment. Psoriasis plaque measurement, psoriasis care and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by a multidisciplinary nurse-led educational program

nurse-led education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cutaneous psoriasis, regardless of the stage of the disease and treatment type (systemic and/or topic, and/or puva therapy)
• Age over 18 years
• Proficiency in the French language

You may not qualify if:

• Valid informed consent is not or cannot be given
• Patients unable to follow the 6-session therapeutic education program
• Patients currently engaged in any other therapeutic education program

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• University of Lausanne Hospitals: collaborator
• University of Lausanne: collaborator

Study Sites (1)

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Conditions

Behavior; Patient Participation

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sebastian E Probst, Prof

  University of Applied Sciences and Arts Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Tissue Viability and Wound Care

Model Details: Quasi-experimental study

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: October 15, 2024
• Primary Completion: June 28, 2025
• Study Completion: September 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)