Atopic DermatitisNCT06032403
Patient with Atopic Dermatitis' Needs for Self-management Support - Flexible Patient Centred Consultations
A study testing flexible patient centred consultations in people with Atopic Dermatitis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- flexible patient centred consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Jan 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A person deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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
- Conditions
- Atopic Dermatitis
- Being tested
- flexible patient centred consultations
- Keywords
- Patient-centred care, Self-management support
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible patient centred consultationsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Consists of 100 participants followed for one year |
| Intervention group | Other | Consists of 100 participants followed for one year Receives: Behavioral: flexible patient centred consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 and 12 months
Secondary outcomes (10)
The Infant Dermatology Life Quality Index (IDLQI)
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.
Measured: baseline, 6 and 12 months
The Dermatology Life Quality Index (DLQI)
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.
Measured: baseline, 6 and 12 months
The Children Dermatology Life Quality Index (CDLQI)
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
Measured: baseline, 6 and 12 months
The Patient Oriented eczema measure (POEM)
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.
Measured: baseline, 6 and 12 months
The Patient Oriented eczema measure for parents (POEM for parents)
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.
Measured: baseline, 6 and 12 months
Eczema And Severity Index (EASI)
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.
Measured: baseline, 6 and 12 months
Pruritus numeric rating scale (Pruritus NRS).
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.
Measured: baseline, 6 and 12 months
The sleep disturbance numeric rating scale (SD NRS)
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.
Measured: baseline, 6 and 12 months
Patient activity measures (PAM)
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
Measured: baseline, 6 and 12 months
Questionnaire about patient and healthcare collaboration (CollaboRATE)
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.
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start31 Jan 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aage Bangs Fond, The Novo Nordic Foundation, Herlev and Gentofte Hospital, Sanofi, Almirall, S.A.
- Responsible party
- Principal investigator, Anna Sophie Belling Krontoft, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032403
- Sponsor's protocol ID
- UHGentofte P-2022-298
- Other IDs
- H-22048513
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient with Atopic Dermatitis' Needs for Self-management Support - Flexible Patient Centred Consultations
- ClinicalTrials.gov ID
- NCT06032403
- Acronym / sponsor ID
- UHGentofte P-2022-298
- Conditions
- Atopic Dermatitis
- Keywords
- Patient-centred care, Self-management support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Aage Bangs Fond, The Novo Nordic Foundation, Herlev and Gentofte Hospital, Sanofi, Almirall, S.A.
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Consists of 100 participants followed for one year |
| Intervention group | Other | Behavioral: flexible patient centred consultationsConsists of 100 participants followed for one year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- A person deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible patient centred consultationsIn 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 | Behavioural | Intervention group |
Primary outcome
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.
10 secondary outcomes
The Infant Dermatology Life Quality Index (IDLQI)
Time frame: baseline, 6 and 12 months
The Dermatology Life Quality Index (DLQI)
Time frame: baseline, 6 and 12 months
The Children Dermatology Life Quality Index (CDLQI)
Time frame: baseline, 6 and 12 months
The Patient Oriented eczema measure (POEM)
Time frame: baseline, 6 and 12 months
The Patient Oriented eczema measure for parents (POEM for parents)
Time frame: baseline, 6 and 12 months
Eczema And Severity Index (EASI)
Time frame: baseline, 6 and 12 months
Pruritus numeric rating scale (Pruritus NRS).
Time frame: baseline, 6 and 12 months
The sleep disturbance numeric rating scale (SD NRS)
Time frame: baseline, 6 and 12 months
Patient activity measures (PAM)
Time frame: baseline, 6 and 12 months
Questionnaire about patient and healthcare collaboration (CollaboRATE)
Time frame: baseline, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible patient centred consultations in people with Atopic Dermatitis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Well-Being Index (WHO-5) (time frame: baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.