Clinical trial NCT03127462: A Nurse-led Individualized Educational Intervention
Official title: Efficiency of a Nurse-led Individualized Educational Intervention in Newly Referred Patients With Psoriasis. A Pragmatic Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the first phase of the study 30 patients will receive standard treatment (control group) and in the following phase 30 patients will receive the individualized conversational/educational intervention (intervention group).The rationale for using a historical control group instead of a randomised control group is that it in"real-life setting" is unpractical to realize a communicative intervention, because clinicians unintentional can intervene against the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 60 newly referred patients with psoriasis at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Denmark will be consecutive included in the study. In the first phase of the study 30 patients will receive standard treatment (control group) and in the following phase 30 patients will receive the individualized conversational/educational intervention (intervention group).The rationale for using a historical control group instead of a randomised control group is that it in"real-life setting" is unpractical to realize a communicative intervention, because clinicians unintentional can intervene against the control group.

The first conversation will take place when the newly referred patient has initiated a new treatment. The rational for this is that the time of transition from private practice to the Department of Dermatology and Allergy is characterised by failed treatment, typically phototherapy or topical. This meaning that newly referred patients current needs is to get their psoriasis under control. When patients have initiated a medical treatment they will be more motivated and have better surplus to engage in the conversational/educational intervention.

Patients in the intervention group will receive an individual face-to-face conversation with a duration of 45 min. All patients will have access to telephone counselling by their primary nurse when needed and able to arrange a new face-to-face conversation. After 4-6 weeks the face-to-face the nurse will of conversation reach out to the patient by phone to follow up on the earlier conversation. Three months after the face-to-face conversation the nurse will offer the patient a closing face-to-face conversation of 15 min at the same time where the patient has a doctor appointment at the department. Those who are in the control group will continue standard care and not receive any conversation and be used as the control group.

The intervention will be provided by a team of specialized dermatological nurses who have received a formal training on patient-centred communication, Self-regulatory Model/Common Sense Model interviewing, the life with chronic disease and action plan support.


Eligibility criteria: Inclusion Criteria:

* Newly referred patients with psoriasis at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, 18 years or older and understand Danish.

Exclusion Criteria:

* Patients younger than 18 years

Primary outcomes:
measure: The brief Illness Perception Questionnaire
timeFrame: Change from Baseline at 3 month follow-up
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: Change from Baseline at 3 month follow-up
Other outcomes:
measure: The Patient Assessment of Chronic Illness Care
timeFrame: Change from Baseline at 3 month follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from Baseline at 3 month follow-up
measure: Body Image Scale
timeFrame: Change from Baseline at 3 month follow-up
measure: Understanding of psoriasis
timeFrame: Change from Baseline at 3 month follow-up
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital, University of Copenhagen
Study officials:
References: