Clinical trial NCT06032403: Patient with Atopic Dermatitis' Needs for Self-management Support - Flexible Patient Centred Consultations
Official title: Patient with Atopic Dermatitis' Needs for Self-management Support - Flexible Patient Centred Consultations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Patient-centred care
Self-management support
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Aage Bangs Fond
name: The Novo Nordic Foundation
name: Herlev and Gentofte Hospital
name: Sanofi
name: Almirall, S.A.
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators start by including 100 participants (control group) who are attending the clinical. The control group will be followed for one year. After the control group has been followed for one year the investigators include 100 participants in the intervention group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators will conduct a controlled trial to investigate the effects of a flexible patient-centred consultation with a focus on self-management support, well-being, treatment content, and self-management skills in patients with atopic dermatitis.

The investigators will include 200 participants; 100 participants in a control group followed by 100 participants in an intervention group. The controlled trial will take place at the outpatient clinic at the Department of Dermatology and Allergy, Herlev-Gentofte Hospital and the daily management will be done by the project manager/Ph.d. student with support from the project group.

In the control group, participants will be provided with care as usual. This means participants will be seen by a doctor and new participants will get an additional nurse session focusing on therapeutic patient education (TPE) in atopic dermatitis. The consultations are scheduled at regular intervals of approximately three months but with alterations if the participant needs to be seen before.

In the intervention group, the set-up will be flexible patient-centred consultations. The first consultation for the participant will be with the doctor and depending on the participant's need, the following consultations can be scheduled with either a doctor- or a nurse consultation. After each consultation, it will be decided in collaboration between the healthcare professionals and the participant whether a nurse or a doctor consultation will be relevant next. The consultations (whether it is with the doctor or nurse) will be centered around the participant's choice of topics by use of an atopic dermatitis dialogue tool developed in the department. Additionally, the nurse consultation will focus on therapeutic patient education (TPE) in atopic dermatitis. The interval between consultations will depend on the participant's need

Detailed description: In this study, the investigators will conduct a controlled trial to investigate the effects of a flexible patient-centred consultation with a focus on self-management support, well-being, treatment content, and self-management skills in patients with atopic dermatitis.

The investigators will include 200 participants; 100 participants in a control group followed by 100 participants in an intervention group. The controlled trial will take place at the outpatient clinic at the Department of Dermatology and Allergy, Herlev-Gentofte Hospital and the daily management will be done by the project manager/Ph.d. student with support from the project group.

In the control group, participants will be provided with care as usual. This means participants will be seen by a doctor and new participants will get an additional nurse session focusing on therapeutic patient education (TPE) in atopic dermatitis. The consultations are scheduled at regular intervals of approximately three months but with alterations if the patients need to be seen before.

In the intervention group, the set-up will be flexible patient-centred consultations. The first consultation for the participant will be with the doctor and depending on the participant's need, the following consultations can be scheduled with either a doctor- or a nurse consultation. After each consultation, it will be decided in collaboration between the healthcare professionals and the participant whether a nurse or a doctor consultation will be relevant next. The consultations (whether it is with the doctor or nurse) will be centered around the participant's choice of topics by use of an atopic dermatitis dialogue tool developed in the department. Additionally, the nurse consultation will focus on therapeutic patient education (TPE) in atopic dermatitis. The interval between consultations will depend on the patient's need

Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of atopic atopic dermatitis
* Children and adolescents under 18 years
* Adults over 18 years
* Need to be followed at the department
* Patient or caregiver must be able to speak and understand Danish
* Received oral and written information
* The patient or caregiver has signed the informed consent

Exclusion Criteria:

* A person deprived of liberty

Primary outcomes:
measure: The Well-Being Index (WHO-5)
timeFrame: baseline, 6 and 12 months
Secondary outcomes:
measure: The Infant Dermatology Life Quality Index (IDLQI)
timeFrame: baseline, 6 and 12 months
measure: The Dermatology Life Quality Index (DLQI)
timeFrame: baseline, 6 and 12 months
measure: The Children Dermatology Life Quality Index (CDLQI)
timeFrame: baseline, 6 and 12 months
measure: The Patient Oriented eczema measure (POEM)
timeFrame: baseline, 6 and 12 months
measure: The Patient Oriented eczema measure for parents (POEM for parents)
timeFrame: baseline, 6 and 12 months
measure: Eczema And Severity Index (EASI)
timeFrame: baseline, 6 and 12 months
measure: Pruritus numeric rating scale (Pruritus NRS).
timeFrame: baseline, 6 and 12 months
measure: The sleep disturbance numeric rating scale (SD NRS)
timeFrame: baseline, 6 and 12 months
measure: Patient activity measures (PAM)
timeFrame: baseline, 6 and 12 months
measure: Questionnaire about patient and healthcare collaboration (CollaboRATE)
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
state: Copenhagen
Study officials:
References: