Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
NCT03722706
Last updated date
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0-16
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of atopic dermatitis
- Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Parent is Spanish speaking
- Parent is foster parent
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook | ||||
| Official Title ICMJE | Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook | ||||
| Brief 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. 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other | ||||
| Condition ICMJE | Dermatitis, Atopic | ||||
| Intervention ICMJE | Other: Educational handbook
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 Arms ICMJE |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 246 | ||||
| Original Estimated Enrollment ICMJE | 240 | ||||
| Actual Study Completion Date ICMJE | March 30, 2020 | ||||
| Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | up to 16 Years (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03722706 | ||||
| Other Study ID Numbers ICMJE | IRB-P00029317 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Jennifer LeBovidge, Boston Children's Hospital | ||||
| Study Sponsor ICMJE | Boston Children's Hospital | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Boston Children's Hospital | ||||
| Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||