Atopic Dermatitis Clinical Trial
Official title:
A Multi-Disciplinary Psychoeducational Prevention for the Treatment of Atopic Dermatitis in Youth and Their Families: A Pilot Study
The goal of the current investigation is to determine whether the inclusion of a parent/patient psychoeducational session in initial dermatology appointments with new pediatric atopic dermatitis patients affects (a) extent of medical follow-up, (b) patient's quality of life, and (c) parenting stress in comparison to treatment as usual for initial pediatric dermatology appointments for new pediatric patients with atopic dermatitis.
Youth will be selected to participate based on request for initial intake appointments
regarding atopic dermatitis or eczema at the Pediatric Dermatology office at 'Specially for
Children. Once consented into the study, youth and parents will be randomized into either
the routine care group (medical visit with nurse and medical provider) or the prevention
group (medical visit with nurse and medical provider, psychoeducation session with
psychologist). Randomization will occur through a pre-determined randomized list. Next,
youth and parents will complete questionnaires (listed above, see Appendix X) in the clinic
setting prior to their appointment with the medical provider. At that time, the intervention
will commence. All patient interaction between the patient, patient's family, and the study
investigators will be conducted at the Pediatric Dermatology Clinic at 'Specially for
Children or Dell Children's Medical Center. Demographic and clinical data will be collected
and de-identified from the patients' medical records. Each condition's details are listed
below along with a flowchart describing the investigation process.
Routine Care Group Initial Evaluation: The family will be requested to fill out all measures
for an initial assessment (Parenting Stress Index, Children's Dermatology Quality of Life
Index/Infant Dermatitis Quality of Life Index, and the Patient Oriented SCORAD). As part of
the medical initial evaluation, the medical provider will complete the SCORAD as part of
his/her medical evaluation. Further, nursing staff will spend time educating the patient and
family about therapy involved in medically treating atopic dermatitis. The total time
estimated to fill out measures and complete initial intake evaluation is about 40 minutes.
First Follow-up Appointment: Patient will be seen two weeks later for a follow-up visit
where the family will complete the Patient Oriented SCORAD and the medical provider will
complete the SCORAD as part of the medical evaluation and recommendations that make up the
follow up appointment. Nursing staff will again spend time educating the patient and family
about therapy involved in medically treating atopic dermatitis to determine that family has
sufficient education regarding care. Additional data collected at this time will be the
number of days since initial visit (collected through medical record).
Two month Follow-up Appointment: Finally, the family will be requested to schedule a 2 month
follow up to fill out all measures again and have a follow up medical visit. Additional data
collected at this time from the medical chart will be number of times the family has
contacted the dermatology office since the initial evaluation appointment. The family will
also be asked to complete a satisfaction survey about their experience at this time.
Prevention Group Initial Evaluation: The family will be requested to fill out all measures
for an initial assessment (Parenting Stress Index, Children's Dermatology Quality of Life
Index/Infant Dermatitis Quality of Life Index, and the Patient Oriented SCORAD). During the
medical part of the visit, the medical provider will complete the SCORAD as part of his/her
medical evaluation. Nursing staff will briefly educate the patient and family about therapy
involved in medically treating atopic dermatitis. Then, the family will meet with the
psychologist for about 30 minutes following medical visit to get psychoeducation and
introduction to coping, sleep, and behavior strategies. The total time estimated to fill out
measures and complete initial intake evaluation is about 50 minutes.
First Follow-up Appointment: Patient will be seen two weeks later for a follow-up visit
where the family will complete the Patient Oriented SCORAD and the medical provider will
complete the SCORAD as part of the medical evaluation and recommendations that make up the
follow up appointment. Additional data collected at this time will be the number of days
since initial visit (collected through medical record). The family will meet with the
psychologist for another 30 minutes a review or elaboration of coping, sleep, and behavior
strategies. Additional data collected at this time will be the number of days since initial
visit (collected through medical record).
Two month Follow-up Appointment: Finally, the family will be requested to schedule a 2 month
follow up to fill out all measures post prevention and have a follow up medical visit.
Additional data collected at this time from the medical chart will be number of times the
family has contacted the dermatology office since the initial evaluation appointment. The
family will also be asked to complete a satisfaction survey about their experience at this
time.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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