A Nurse-led Individualized Educational Intervention
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nurse-led educational intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis
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
Sites / Locations
- Gentofte Hospital, University of CopenhagenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Individualized Education
Control group
Arm Description
Outcomes
Primary Outcome Measures
The brief Illness Perception Questionnaire
Illness perception
Secondary Outcome Measures
Dermatology Life Quality Index
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03127462
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lina R. Khoury
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized Education
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The brief Illness Perception Questionnaire
Description
Illness perception
Time Frame
Change from Baseline at 3 month follow-up
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Description
Quality of life
Time Frame
Change from Baseline at 3 month follow-up
Other Pre-specified Outcome Measures:
Title
The Patient Assessment of Chronic Illness Care
Description
Perception of Care
Time Frame
Change from Baseline at 3 month follow-up
Title
Hospital Anxiety and Depression Scale
Description
Anxiety and depression
Time Frame
Change from Baseline at 3 month follow-up
Title
Body Image Scale
Description
Body image
Time Frame
Change from Baseline at 3 month follow-up
Title
Understanding of psoriasis
Description
Patients understanding of psoriasis by a self-developed questionnaire
Time Frame
Change from Baseline at 3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Khoury
Phone
38673141
Email
lkho0011@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Skov
Facility Information:
Facility Name
Gentofte Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Khoury, B.N, stud.scient.san
Phone
0045 38673141
Email
lina.rouyouf.khoury.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Lone Skov, professor, dr.med
Phone
0045 38673204
Email
lone.skov.02@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Nurse-led Individualized Educational Intervention
We'll reach out to this number within 24 hrs