A Nurse-led Individualized Educational Intervention
Study Purpose
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 Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03127462 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Lina R. Khoury |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Denmark |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
Contact a Trial Team
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