A Nurse-led Individualized Educational Intervention

Efficiency of a Nurse-led Individualized Educational Intervention in Newly Referred Patients With Psoriasis. A Pragmatic Controlled Study.

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Behavioral: Nurse-led educational intervention

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Khoury; Phone Number: 38673141; Email: lkho0011@regionh.dk
• Study Contact Backup: Name: Lone Skov

Study Locations

• Denmark
  • Copenhagen, Denmark, 2900
    • Recruiting
    • Gentofte Hospital, University of Copenhagen
    • Contact: Lina Khoury, B.N, stud.scient.san; Phone Number: 0045 38673141; Email: lina.rouyouf.khoury.01@regionh.dk
    • Contact: Lone Skov, professor, dr.med; Phone Number: 0045 38673204; Email: lone.skov.02@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Individualized Education	Behavioral: Nurse-led 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The brief Illness Perception Questionnaire	Illness perception	Change from Baseline at 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index	Quality of life	Change from Baseline at 3 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Patient Assessment of Chronic Illness Care	Perception of Care	Change from Baseline at 3 month follow-up
Hospital Anxiety and Depression Scale	Anxiety and depression	Change from Baseline at 3 month follow-up
Body Image Scale	Body image	Change from Baseline at 3 month follow-up
Understanding of psoriasis	Patients understanding of psoriasis by a self-developed questionnaire	Change from Baseline at 3 month follow-up

Collaborators and Investigators

• Sponsor: Lina R. Khoury

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: UA-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No