A Nurse-led Individualized Educational Intervention

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03127462
• Other study ID #: UA-1502
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: February 16, 2018
• Start date: May 1, 2017
• Est. completion date: August 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Lina Khoury
• Phone: 38673141
• Email: lkho0011[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Lina R. Khoury

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Patient Assessment of Chronic Illness Care	Perception of Care	Change from Baseline at 3 month follow-up
Other	Hospital Anxiety and Depression Scale	Anxiety and depression	Change from Baseline at 3 month follow-up
Other	Body Image Scale	Body image	Change from Baseline at 3 month follow-up
Other	Understanding of psoriasis	Patients understanding of psoriasis by a self-developed questionnaire	Change from Baseline at 3 month follow-up
Primary	The brief Illness Perception Questionnaire	Illness perception	Change from Baseline at 3 month follow-up
Secondary	Dermatology Life Quality Index	Quality of life	Change from Baseline at 3 month follow-up