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

NCT06032403 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

flexible patient centred consultations

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

Sponsors & Collaborators

  • Aage Bangs Fond

    collaborator OTHER
  • The Novo Nordic Foundation

    collaborator OTHER
  • Herlev and Gentofte Hospital

    collaborator OTHER
  • Sanofi

    collaborator INDUSTRY
  • Almirall, S.A.

    collaborator INDUSTRY
  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032403 on ClinicalTrials.gov