Atopic DermatitisAD-TPENCT04352270
Clinic-Based Atopic Dermatitis Therapeutic Patient Education
A study testing AD printed educational materials and AD educational videos in people with Atopic Dermatitis, run by Boston University at 1 site in United States.
Trial summary
The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- AD printed educational materials and AD educational videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 21 Sep 2023
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian
- Spanish or English speakers
- Have access to the internet
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
BMC Pediatric Dermatology Clinics
Boston, Massachusetts, 02118
About this study
Official title: A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. The clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (AD), and the amount of itch experienced.
Read the detailed description
Patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.The patient participants will be children anywhere on the spectrum of mild to severe AD and they will be stratified into four strata: a) Those with severe AD and no medical intervention escalation, b) Those with mild AD and no medical intervention escalation, c) Those with severe AD and medical intervention escalation, and d) Those with mild AD and medical intervention escalation. Group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of TPE. Subjects will be recruited in clinic after they are screened for AD during their regular dermatology appointment. The research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. If they agree to participate, a consent/permission form will be given to the parent/guardian to sign. After an initial evaluation of the patient's AD, subjects will receive an initial survey and POEM questionnaire on an iPad via RedCap that will address the condition of their AD. The patient will be administered a form of TPE as the intervention. The intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. A follow-up appointment will be scheduled for the patient. Group 2 will receive a slip of paper with a link to the videos, so the TPE will be accessible outside the clinic.
- Conditions
- Atopic Dermatitis
- Being tested
- AD printed educational materials, AD educational videos
- Keywords
- Therapeutic patient education, Printed handouts, Educational videos, Child-parent dyads
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD printed educational materialsOther
Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.
AD educational videosOther
Short, educational videos in English and Spanish about coping with Atopic Dermatitis, specifically geared towards children and parents will be developed. There will be Spanish and English versions of the videos, minimal text, comprehensive language, animations, and it will be administered via user friendly platforms or websites.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Printed educational materials | Active comparator | Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis. Receives: Other: AD printed educational materials |
| Group 2- Educational videos | Experimental | Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis. Receives: Other: AD educational videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
The Patient Oriented Eczema Measure (POEM) is a validated 7 item instrument with response categories from 0 to 4 where No days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3, Every day = 4. Scoring for the POEM ranges form 0 to 28 and is interpreted by 0 to 2 = Clear or almost clear, 3 to 7 = Mild eczema, 8 to 16 = Moderate eczema, 17 to 24 = Severe eczema, 25 to 28 = Very severe eczema.
Measured: baseline, up to 2 months
Change in eczema severity based on the Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The suggested severity strata for the EASI are: 0 = clear; 0·1-1·0 = almost clear; 1·1-7·0 = mild; 7·1-21·0 = moderate; 21·1-50·0 = severe; 50·1-72·0 = very severe
Measured: baseline, up to 2 months
Change in the severity of itch
An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.
Measured: baseline, up to 2 months
Change in sleep quality
An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.
Measured: baseline, up to 2 months
Secondary outcomes (5)
Change in the overall quality of life
An investigator developed survey completed by participants with questions about quality of life will be used to collect data to assess this outcome.
Measured: baseline, up to 2 months
Change in patient/parent confidence
An investigator developed survey completed by participants with questions about confidence will be used to collect data to assess this outcome.
Measured: baseline, up to 2 months
Change in knowledge of coping with Atopic Dermatitis (AD)
An investigator developed survey completed by participants with questions about their knowledge of coping with AD will be used to collect data to assess this outcome.
Measured: baseline, up to 2 months
Satisfaction with therapeutic patient education (TPE)
An investigator developed survey completed by participants with questions about their satisfaction about TPE will be used to collect data to assess this outcome.
Measured: up to 2 months
Atopic Dermatitis related costs
Billing records will be analyzed to assess AD related costs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start27 Feb 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
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.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Lee, MD PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352270
- Sponsor's protocol ID
- H-39538
- Acronym
- AD-TPE
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2020
- Last updated
- 5 Mar 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
- ClinicalTrials.gov ID
- NCT04352270
- Acronym / sponsor ID
- AD-TPE / H-39538
- Conditions
- Atopic Dermatitis
- Keywords
- Therapeutic patient education, Printed handouts, Educational videos, Child-parent dyads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 20 Apr 2020 (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.
The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. The clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (AD), and the amount of itch experienced.
Detailed description
Patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.The patient participants will be children anywhere on the spectrum of mild to severe AD and they will be stratified into four strata: a) Those with severe AD and no medical intervention escalation, b) Those with mild AD and no medical intervention escalation, c) Those with severe AD and medical intervention escalation, and d) Those with mild AD and medical intervention escalation. Group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of TPE. Subjects will be recruited in clinic after they are screened for AD during their regular dermatology appointment. The research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. If they agree to participate, a consent/permission form will be given to the parent/guardian to sign. After an initial evaluation of the patient's AD, subjects will receive an initial survey and POEM questionnaire on an iPad via RedCap that will address the condition of their AD. The patient will be administered a form of TPE as the intervention. The intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. A follow-up appointment will be scheduled for the patient. Group 2 will receive a slip of paper with a link to the videos, so the TPE will be accessible outside the clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- Printed educational materials | Active comparator | Other: AD printed educational materialsParent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis. |
| Group 2- Educational videos | Experimental | Other: AD educational videosParent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian
- Spanish or English speakers
- Have access to the internet
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AD printed educational materialsPrinted educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants. | Other | Group 1- Printed educational materials |
| AD educational videosShort, educational videos in English and Spanish about coping with Atopic Dermatitis, specifically geared towards children and parents will be developed. There will be Spanish and English versions of the videos, minimal text, comprehensive language, animations, and it will be administered via user friendly platforms or websites. | Other | Group 2- Educational videos |
Primary outcome
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
Time frame: baseline, up to 2 months
The Patient Oriented Eczema Measure (POEM) is a validated 7 item instrument with response categories from 0 to 4 where No days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3, Every day = 4. Scoring for the POEM ranges form 0 to 28 and is interpreted by 0 to 2 = Clear or almost clear, 3 to 7 = Mild eczema, 8 to 16 = Moderate eczema, 17 to 24 = Severe eczema, 25 to 28 = Very severe eczema.
Change in eczema severity based on the Eczema Area and Severity Index (EASI)
Time frame: baseline, up to 2 months
The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The suggested severity strata for the EASI are: 0 = clear; 0·1-1·0 = almost clear; 1·1-7·0 = mild; 7·1-21·0 = moderate; 21·1-50·0 = severe; 50·1-72·0 = very severe
Change in the severity of itch
Time frame: baseline, up to 2 months
An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.
Change in sleep quality
Time frame: baseline, up to 2 months
An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.
5 secondary outcomes
Change in the overall quality of life
Time frame: baseline, up to 2 months
Change in patient/parent confidence
Time frame: baseline, up to 2 months
Change in knowledge of coping with Atopic Dermatitis (AD)
Time frame: baseline, up to 2 months
Satisfaction with therapeutic patient education (TPE)
Time frame: up to 2 months
Atopic Dermatitis related costs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Margaret Lee, MD PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AD printed educational materials and AD educational videos in people with Atopic Dermatitis, run by Boston University at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 5 Mar 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM) (time frame: baseline, up to 2 months). The study lists 4 primary outcomes in all. 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 5 Mar 2024.