Dermatitis, AtopicNCT03722706
Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
A study testing Educational handbook in people with Dermatitis, Atopic, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. Read more about this study
- Who is it for?
- Ages 30 days to 16 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Educational handbook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 30 Mar 2020
- 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 30 days to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of atopic dermatitis
- Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital
Who cannot join
- Parent is Spanish speaking
- Parent is foster parent
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. The handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (AD). Patient education is an important element of practice management guidelines for AD, particularly given complex treatment plans and high rates of non-adherence in this population. Parents of children with AD will be randomized into either the handbook arm (handbook provided as an adjunct to standard AD management with a healthcare provider at Boston Children's Hospital) or the control arm (standard management alone). Participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for AD care at Boston Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the handbook.
- Conditions
- Dermatitis, Atopic
- Being tested
- Educational handbook
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational handbookOther
The intervention being evaluated in this study is an educational handbook for parents of children with atopic dermatitis (AD). The handbook was developed and written by the interdisciplinary study team (psychologist, allergist, nurse practitioner, dermatologists, primary care physician, dietitian). Content was based on practice guidelines for AD management, consensus recommendations for therapeutic patient education for AD, and clinical experience of our study team. Content includes topics central to effective AD management, such as pathophysiology/course, elements of treatment plans, and strategies to improve quality of life, such as breaking the itch-scratch cycle, improving sleep, and coping with social-emotional issues.
| Study group | Role | What they receive |
|---|---|---|
| Handbook | Experimental | handbook provided as an adjunct to standard AD management with a healthcare provider at BCH Receives: Other: Educational handbook |
| Control | No intervention | standard management alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Oriented Eczema Measure (POEM)
parent-report of child's atopic dermatitis symptoms
Measured: baseline to 3-month follow-up
Secondary outcomes (4)
Eczema Area and Severity Index (EASI)
healthcare provider-rating of atopic dermatitis severity
Measured: baseline to 3-month follow-up
Infant's Dermatitis Quality of Life Index (IDQOL)
Quality of life associated with atopic dermatitis (for patients under 4 years)
Measured: baseline to 3-month follow-up
Children's Dermatology Life Quality Index (CDLQI)
Quality of life associated with atopic dermatitis (for patients 4-16 years)
Measured: baseline to 3-month follow-up
Dermatology Family Impact Questionnaire (DFI)
Parent quality of life associated with atopic dermatitis
Measured: baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start26 Feb 2019
- Primary completion15 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jennifer LeBovidge, Boston Children's Hospital
- Investigators
- Jennifer S LeBovidge, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722706
- Sponsor's protocol ID
- IRB-P00029317
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2018
- Last updated
- 17 Jul 2020
- 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
- ClinicalTrials.gov ID
- NCT03722706
- Acronym / sponsor ID
- IRB-P00029317
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 29 Oct 2018 (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 objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. The handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (AD). Patient education is an important element of practice management guidelines for AD, particularly given complex treatment plans and high rates of non-adherence in this population. Parents of children with AD will be randomized into either the handbook arm (handbook provided as an adjunct to standard AD management with a healthcare provider at Boston Children's Hospital) or the control arm (standard management alone). Participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for AD care at Boston Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the handbook.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handbook | Experimental | Other: Educational handbookhandbook provided as an adjunct to standard AD management with a healthcare provider at BCH |
| Control | No intervention | –standard management alone |
Who may qualify
- Ages
- 30 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of atopic dermatitis
- Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital
Key exclusion criteria (2 listed)
- Parent is Spanish speaking
- Parent is foster parent
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 |
|---|---|---|
| Educational handbookThe intervention being evaluated in this study is an educational handbook for parents of children with atopic dermatitis (AD). The handbook was developed and written by the interdisciplinary study team (psychologist, allergist, nurse practitioner, dermatologists, primary care physician, dietitian). Content was based on practice guidelines for AD management, consensus recommendations for therapeutic patient education for AD, and clinical experience of our study team. Content includes topics central to effective AD management, such as pathophysiology/course, elements of treatment plans, and strategies to improve quality of life, such as breaking the itch-scratch cycle, improving sleep, and coping with social-emotional issues. | Other | Handbook |
Primary outcome
Patient-Oriented Eczema Measure (POEM)
Time frame: baseline to 3-month follow-up
parent-report of child's atopic dermatitis symptoms
4 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: baseline to 3-month follow-up
Infant's Dermatitis Quality of Life Index (IDQOL)
Time frame: baseline to 3-month follow-up
Children's Dermatology Life Quality Index (CDLQI)
Time frame: baseline to 3-month follow-up
Dermatology Family Impact Questionnaire (DFI)
Time frame: baseline to 3-month follow-up
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 17 Jul 2020.
- 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.
Jennifer S LeBovidge, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational handbook in people with Dermatitis, Atopic, run by Boston Children's Hospital 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 2 inclusion and 2 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 17 Jul 2020. 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?
Patient-Oriented Eczema Measure (POEM) (time frame: baseline to 3-month follow-up). 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 17 Jul 2020.