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

September 4, 2023 updated by: Anna Sophie Belling Krontoft, University Hospital, Gentofte, Copenhagen

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Consists of 100 participants followed for one year
Other: Intervention group
Consists of 100 participants followed for one year
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Well-Being Index (WHO-5)
Time Frame: baseline, 6 and 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Infant Dermatology Life Quality Index (IDLQI)
Time Frame: baseline, 6 and 12 months

The Infant Dermatology Quality of Life Index contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant.

The index is filled out by a parent to a participating child between the ages of 0 to 5 years.

Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life.
baseline, 6 and 12 months
The Dermatology Life Quality Index (DLQI)
Time Frame: baseline, 6 and 12 months

The Dermatology Life Quality Index contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant.

The index is filled out by participants over the age of 15 years.

Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life.
baseline, 6 and 12 months
The Children Dermatology Life Quality Index (CDLQI)
Time Frame: baseline, 6 and 12 months

The Children Dermatology Life Quality Index contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant.

Question number 7 is only applicable if the participant is attending school.

The index is filled out by participants (a parent when the participant is between 5 and 10 years old and the participant themselves when the participant is between 10-15 years old).

Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life
baseline, 6 and 12 months
The Patient Oriented eczema measure (POEM)
Time Frame: baseline, 6 and 12 months

A subjective patient measure of eczema severity.

The questionnaire contains 7 questions and a response scale with 5 options. Each option gives a point between 0 and 4. The sum score is found by adding the points together. The sum score can be between 0-28. The higher the sum score the worse the assumed severity of eczema.

The questionnaire is filled out by participants over the age of 15 years.
baseline, 6 and 12 months
The Patient Oriented eczema measure for parents (POEM for parents)
Time Frame: baseline, 6 and 12 months

A subjective patient measure of eczema severity.

The questionnaire contains 7 questions and a response scale with 5 options. Each option gives a point between 0 and 4. The sum score is found by adding the points together. The sum score can be between 0-28. The higher the sum score the worse the assumed severity of eczema.

The questionnaire is filled out by a parent to a participant under the age of 10 years and together with the participant if the participant is between 10 and 15 years old.
baseline, 6 and 12 months
Eczema And Severity Index (EASI)
Time Frame: baseline, 6 and 12 months

Assessment of eczema severity. Filled out by healthcare professionals at consultation visits.

The EASI contains of a severity score between 0-3 and an area score between 0-6. These scores are given for each of the four body regions (head and neck, trunk, over-extremities, and under-extremities). The minimum EASI score is 0 and the maximum EASI score is 72. The higher the sum-score the worse the eczema severity.
baseline, 6 and 12 months
Pruritus numeric rating scale (Pruritus NRS).
Time Frame: baseline, 6 and 12 months

Scale for measuring itch. Consists of a horizontal line with 11 boxes going from 0 to 10 (from left to right). 0 being no itch and 10 being the worst imaginable itch. The scale is answered two times first thinking about the last 24 hours and secondly thinking about an average over the last 7 days. The sum-score for is calculated for each question and can be between 0 and 10. The higher the score the worse the pruritus is.

The scale is filled out by participants over the age of 15 years. By a parent together with the participant if the participant is between 10-15 years old. By a parent to a participant if the participant is under 10 years old.
baseline, 6 and 12 months
The sleep disturbance numeric rating scale (SD NRS)
Time Frame: baseline, 6 and 12 months

Scale for measuring sleep disturbance. Consists of a horizontal line with 11 boxes going from 0 to ten (from left to right). 0 being no sleep disturbance and 10 being I can´t sleep at all. The scale is answered two times first thinking about the last 24 hours and secondly thinking about an average over the last 7 days. The sum-score is calculated for each question and can be between 0 and 10. The higher the score the worse the sleep disturbance is considered.

The scale is filled out by participants over the age of 15 years. By a parent together with the participant if the participant is between 10-15 years old. By a parent to a participant if the participant is under 10 years old.
baseline, 6 and 12 months
Patient activity measures (PAM)
Time Frame: baseline, 6 and 12 months

For measuring patient activation (self-management). The scale consists of 13 questions with a response scale of 5 boxes (highly disagree, disagree, agree, very much agree, and don't know). Each answer corresponds to a point between 0-4.

The raw sum score is done by adding each point and dividing the point total by the number of items completed with a 1-4. and then multiply by 13. Secondly, the investigators convert the raw score into the activation score by using the "Insignia health License package". The activation score can be between 0 and 100. The higher the score the less patient activity in regards to the disease (atopic dermatitis).

The PAM is filled out by participants over 15 years of age
baseline, 6 and 12 months
Questionnaire about patient and healthcare collaboration (CollaboRATE)
Time Frame: baseline, 6 and 12 months
Scale for measuring involvement of the patient in the consultation. The scale consist of three questions each with a response scale going from 0-9 (0 = not at all and 9 = to a high degree). The sum score is done by adding the points from each question. The sum score can be between 0-27. The higher the score the better the assumed involvement of the patient in the consultation.
baseline, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Sanofi
Aage Bangs Fond
The Novo Nordic Foundation
Herlev and Gentofte Hospital
Almirall, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHGentofte P-2022-298
  • H-22048513 (Other Identifier: The National Committee on Health Research Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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