Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05715190 |
| Other study ID # |
Psoriasis |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
School of Health Sciences Geneva |
| Contact |
Sebastian Probst, Prof |
| Phone |
+41 22 558 50 60 |
| Email |
sebastian.probst[@]hesge.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. Introduction 1.1. Background and rationale Psoriasis is a systemic, immune-mediated
disorder, characterized by inflammatory skin and joint manifestations that affects patient's
quality of life, especially on a psychological, body aesthetic and social level, and
therefore can impair not only their treatment adherence and sustainability of treatment but
also patient-health care professional relationships. The psoriasis prevalence in adults in
Europe ranges from 2% to 3%. If these findings are applied to the Swiss context it would mean
that there are an estimated 180'000 persons suffering from psoriasis in Switzerland. The
incidence increases with age making psoriasis a global health problem. Psoriasis can manifest
in many different forms and is classified based on the severity of the disease into mild,
moderate and severe. It is a chronic and recurrent disease being visible mostly on skin,
which is characterized by alternating phases of outbreaks and remissions and whose evolution
can vary greatly from one individual to another. Regardless of the severity, this chronic
skin disease requires a long-term treatment strategy. Due to the visibility of lesions in
patients and the inadequate understanding of this disease in public, individuals with
psoriasis often suffer from stigma in their daily lives, which has adverse effects on their
self-efficacy, mental health, quality of life, and therapeutic responses. A systematic review
and meta-analysis by Xiao et al. show that for individuals suffering from psoriasis there are
a variety of psychological intervention methods that are widely applied nowadays, among which
cognitive behavioral therapy is the most recognized in the field. Cognitive behavioral
therapy can reduce the stigma and confusion surrounding affective and anxiety responses to
the disease, and it may improve psoriasis severity by inhibiting the inflammation associated
with depression and anxiety. Consequences of stigmatization are low self-efficacy.
Self-efficacy refers to an individual's self-perceived ability to act effectively in a
variety of situations enhancing their activities of daily living. It is an important factor
that influences the individual's ability to self-manage symptoms of their chronic diseases.
Self-efficacy plays an important role in determining whether self-care actions are initiated,
how much effort is exerted, and how long the effort is sustained in the face of obstacles and
failures. Evidence demonstrates that if individuals with high self-efficacy in coping with
their chronic diseases reflect a perceived ability to manage challenges related to their
diseases and a sense of control over their lives. Self-efficacy in patients with psoriasis
can be enhanced by education, acquiring coping skills through shared experiences or
psychological support systems. Hence, psoriasis is a burden not only on the affected persons
themselves, causing suffering and requiring lifelong management and treatments, but also on
their close relatives and on society as a whole.
The care of patients with psoriasis has become, due to its complex chronic condition and
course of disease, a specialty on its own. Traditionally, the therapeutic approach to the
management of psoriasis is a multifaceted mostly medical approach determined by the type, the
severity of the psoriasis, and the area of skin affected. Even though the etiology is not yet
fully understood, traditionally, medical treatment options to decrease disease activity and
improve symptoms are multifaceted including topical application of creams, phototherapy
and/or systemic therapy. Topical treatment is mainly for mild or moderate psoriasis. This
treatment includes ointments such as calcipotriol, calcineurin inhibitors, tretinoin,
glucocorticoid, medicated bath with diastase or herbal extracts, and phototherapy.
Phototherapy is an effective, safe, and accessible treatment without incurring any systemic
side effects and can be combined with biologic agents for the treatment of more severe
psoriasis. The systemic treatment involves conventional and newer oral or injectable systemic
agents and biologics such as immune inhibitors, immune modulators or tumor necrosis factor α
antagonists. Evidence reports an association between psoriasis severity and metabolic
comorbidities, anxiety, depression, smoking, and alcohol abuse. An early diagnosis of these
associated diseases, the implementation of treatment and adoption of healthy lifestyle are
important in addition to the treatment of psoriasis symptoms to improve the prognosis.
In psoriasis patients, the level of knowledge about the pathogenesis and treatment of the
disease has been shown to be insufficient. Evidence demonstrates that after six months a
weekly two hours-educative session providing information on different aspects of psoriasis -
including genetics, mechanisms, precipitating factors, course of the disease, preventive
measures, co-morbidities, daily care of skin and treatment options, as well as
psycho-educational guidance - can improve patient knowledge, and provide better coping
strategies with the disease and better attitude towards therapy. A reduction of the psoriasis
severity was reported by Bostoen and colleagues. They provided a physician driven education
program about stress-reduction techniques with a 12-week education program (2h sessions twice
a week), observing a reduction of disease severity and an improvement of quality of life,
physical activity and depression status. These results are confirmed by Bubak's et al.
prospective controlled study with 53 participants (24 IG, 29 CG), showing an increase in
knowledge, self-expertise about the disease and amelioration of general health when
participating in an educational program consisting in two 2h-workshops dealing with details
on the etiology, pathogenesis, comorbidities, treatment options, nutrition, exercise, and
addictions compared to usual care. However, there were no positive short-term effects seen on
the quality of life and therapy adherence. A more recent study by Jendoubi and colleagues
with 142 patients demonstrate that a standardized physician-led education program consisting
of five sessions over 3 months improves patient knowledge and satisfaction but has no
positive effect on quality of life of patients. Moreover, the results show that the program
did not improve disease severity as well, which is in contradiction with the study of Bostoen
and colleagues. Similarly, a randomized controlled trial including 64 psoriasis patients show
no differences in psoriasis severity in participants attending a physician-led educational
program consisting of 2-h sessions twice a week for 9 weeks versus the control group (IG:
5/46 [35.7%] vs.CG: 5/16 [31.3%]; p = 1.000). Hence, an educative program can allow to
improve patient knowledge and satisfaction, but inconsistencies remain concerning its impact
on the evolution of psoriasis severity and quality of life. Further studies are needed to
optimize education programs improving disease severity and quality of life and how the
benefits of such programs will evolve on the long-term needs also to be clarified.
Evidence reports that 26.6% of patients have low health literacy (HL) which is a higher
percentage than the one observed for other chronic conditions. Health literacy is defined as
knowledge of health, healthcare and health systems as well as processing and using
information in various formats in relation to health and healthcare; and the ability to
maintain health through self-management and working in partnerships with health providers.
Low HL is associated with lower education, decreased communication with health care
professionals, decreased ability to self-care, and higher psoriasis severity. High HL is a
predictor of higher quality of life, self-efficacy, knowledge and reduced psoriasis severity.
HL is therefore an important factor that may influence adherence to therapy and clinical
outcomes in psoriasis patients. A cross-sectional study investigated the association between
HL and psoriasis education from health care professionals in a cohort of 825 psoriasis
patients using a 3 week-program (Climate Helio Therapy). Patients following the three-week
program had a higher HL score (Cohen's effect size: 0.24 to 0.44), higher self-management and
more psoriasis knowledge compared to participants who did not follow this program. However,
this study didn't investigate the effectiveness of this program on psoriasis severity.
Nurses play an important and critical role in healthcare. The participation of nurses in
comprehensive disease management is in countries such as the UK are well established. In
Switzerland, this is slowly evolving, even though specialized nurses could take over more
substantial aspects of patient care. Even though the nursing role is complementary to the one
of a physician by advocating for health promotion, educate patients and the public on the
prevention of illness, provide care and assist in cure, participate in rehabilitation, and
provide support. This means that nurses have the opportunity to play a key role in
transforming the health care system to create a more accessible, high-quality, and
value-driven environment for patients. However, nowadays this role is inconsistently reported
and is still poorly implemented in dermatology settings. In the field of wound care, this
role is more established because nurses developed nurse-led wound clinics for complex wounds
focusing mainly on education. Different modalities of patient education for example in the
care of patients with venous leg ulcers have been reported including individual sessions,
group sessions, telephone calls, web app based, audio-visual based, information leaflet or
brochure. Evidence demonstrates that the use of various modalities may improve learning
outcomes. Supporting information such as audiovisual or written content is important as
people retain only a small amount of information from consultations. The majority of the
education programs described above in psoriasis population are based on individual or group
sessions. Only one pilot randomized controlled trial by Ersser and colleagues uses
audio-visual, written materials and telephone calls in addition to group sessions, and
another uses web app based education alone. However, research is needed to define the most
appropriate model of nurse-led education program and to evaluate its effect on disease
severity and quality of life. Therefore, we seek to develop a nurse-led educational
intervention for psoriasis patients using selected educational modalities, evaluate its
feasibility in clinical practice, and measure its impact on psoriasis severity in regards to
quality of life, health literacy, and patient benefit.
