Patient with Atopic Dermatitis' Needs for Self-management Support - Flexible Patient Centred Consultations

NCT06032403 | Active Not Recruiting

• 2 other identifiers: UHGentofte P-2022-298H-22048513
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Keywords

Patient-centred care; Self-management support

Outcome Measures

Primary Outcomes (1)

• The Well-Being Index (WHO-5)

  Well-Being Index: WHO-5. WHO-5 is validated for adults and children down to 10-years-old, but as research state that the whole family is affected by the burden of a child's atopic dermatitis, the parent attending a consultation with a child at or under 10 years old will be asked to answer the WHO-5 according to how they believe the participant are feeling. The WHO-5 contains of five statements and a response scale that goes from 0-5 (five representing the highest positive well-being for the participant). Points from each question are added together and the sum is multiplied by 4. That will give a number between 0-100. The higher sum score the better the well-being.

  baseline, 6 and 12 months

Secondary Outcomes (10)

• The Infant Dermatology Life Quality Index (IDLQI)

  baseline, 6 and 12 months

• The Dermatology Life Quality Index (DLQI)

  baseline, 6 and 12 months

• The Children Dermatology Life Quality Index (CDLQI)

  baseline, 6 and 12 months

• The Patient Oriented eczema measure (POEM)

  baseline, 6 and 12 months

• The Patient Oriented eczema measure for parents (POEM for parents)

  baseline, 6 and 12 months

Study Arms (2)

Control group

NO INTERVENTION

Consists of 100 participants followed for one year

Intervention group

OTHER

Consists of 100 participants followed for one year

Behavioral: flexible patient centred consultations

Interventions

flexible patient centred consultations BEHAVIORAL

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 as 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

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A person deprived of liberty

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Aage Bangs Fond: collaborator
• The Novo Nordic Foundation: collaborator
• Herlev and Gentofte Hospital: collaborator
• Sanofi: collaborator
• Almirall, S.A.: collaborator

Study Sites (1)

Gentofte University Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse specialist at the Department of Dermatology and Allergy, Principal investigator and PhD student

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: January 31, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)