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

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ClinicalTrials.gov Identifier: NCT05715190
Recruitment Status : Not yet recruiting
First Posted : February 6, 2023
Last Update Posted : February 8, 2023
University of Lausanne Hospitals
Information provided by (Responsible Party):
Sebastian Probst, School of Health Sciences Geneva

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 randomized controlled feasibility study in a psoriasis outpatient clinic in Western Switzerland. Twenty eligible patients with psoriasis will be randomized to receive either a multidisciplinary education and usual care or only usual care, 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.

Condition or disease Intervention/treatment Phase
Self-Management Behavior Patient Empowerment Other: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Development and Feasibility of a Nurse-led Person-centered Education Program on Percentage Reduction of Psoriasis in Persons With Psoriasis: a Pilot Study
Estimated Study Start Date : May 1, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
No Intervention: Control
Visiting the medical psoriasis outpatient clinic. Receiving a medical consultation, phototherapy and methotrexate treatment.
Usual care as described for the CG will also be provided to the IG (visit to the outpatient clinic as prescribed by the physician). 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
Other: Education

Education- topics of the sessions are the following:

  • Discover and understand patient's trajectory with psoriasis
  • Knowledge of the etiology and pathophysiology of psoriasis (genetic and environmental risk factors)
  • Knowledge about treatment and its management (acquisition and maintenance of self-care skills, empowerment and enhancement of coping skills)
  • Disease management and patient adaptation to different situations
  • Educational goals setting
  • Maintenance and updating of the goals

Primary Outcome Measures :
  1. percentage reduction of psoriasi [ Time Frame: 6 weeks ]
    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).

Secondary Outcome Measures :
  1. Health Literacy [ Time Frame: 6 weeks ]
    French version of the Health Literacy Survey European Questionnaire (HLS-EU-Q). scoring: 0 represented the lowest health literacy and 50 the highest health literacy

  2. Patient benefit [ Time Frame: 6 weeks ]
    patient benefit index short form (PBI-S) identifying patient needs by measuring the patient-relevant benefit of treatment, Patients with PBI-S ≥ 1 are considered having at least minimum patient-relevant treatment benefit

  3. Life Quality Index [ Time Frame: 6 weeks ]
    French version of the Dermatology Life Quality Index (DLQI) questionnaire

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05715190

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Contact: Sebastian Probst, Prof +41 22 558 50 60 sebastian.probst@hesge.ch

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Centre hospitalier universitaire vaudois
Lausanne, VD, Switzerland, 1005
Sponsors and Collaborators
School of Health Sciences Geneva
University of Lausanne Hospitals
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Principal Investigator: Sebastian E Probst, Prof University of Applied Sciences and Arts Western Switzerland
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Responsible Party: Sebastian Probst, Full Professor of Tissue Viability and Wound Care, School of Health Sciences Geneva
ClinicalTrials.gov Identifier: NCT05715190    
Other Study ID Numbers: Psoriasis
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Open data source, Yareta

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastian Probst, School of Health Sciences Geneva:
patient education
self management
behavior change