Reducing Health Disparities for Inner-City Children Suffering From Asthma Research Proposal

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The intervention will be adapted from the intervention used by Julian et al. (2014) and will involve three educational sessions providing progressively more detailed information and intensive counseling. On the same day as the initial evaluation the patient and caregiver will be provided with general information about childhood asthma and treatment modalities. The time allotted for this encounter will be 30 minutes. The nurse will provide this information and answer any questions the patient or caregiver may have. A second encounter lasting 2 hours will occur between 2 and 4 weeks following the initial evaluation and will provide a more detailed presentation of asthma pathophysiology, disease course, and the benefits and risks of treatment modalities. This group counseling session will be attended by patients and caregivers from up to four families and administered by both a nurse and pulmonologist. This session is expected to last between 1.5 and 2.0 hours. The third session will occur a month later, approximately 6 to 8 weeks following the initial evaluation. This will also be a group session and provide an overview of the material presented during the second session, but with more time allotted for questions and answers. The same nurse and doctor will administer this session and the time allotted will be 1 to 2 hours depending on the needs of the attendees. The goal of the final and third session is to promote the retention of the material covered during the second session and allow for any and all questions to be asked by both patients and caregivers.

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Research Proposal on Reducing Health Disparities for Inner-City Children Suffering From Asthma Assignment

All children enrolled in the study, regardless of group assignment, will receive standard care. This includes evaluation with spirometry, as recommended by the American Academy of Allergy, Asthma and Immunology (Johnson, & Theurer, 2014). Generally speaking, a diagnosis of asthma will depend on a ratio less than 85% of predicted for FEV1/forced vital capacity (FVC), normal FVC, and a greater than 12% recovery of FEV1 or FVC following bronchodilator challenge, with or without evidence of an obstructive defect, although additional testing may be required. A comprehensive patient history will be taken to evaluate the patient and parents concerning a history of wheezing, eczema, allergic rhinitis, parental asthma, exacerbation frequency, and environmental triggers, in addition to a physical examination (Watts, 2009). Disease management will be based on published treatment guidelines (Watts, 2009) and will at a minimum involve inhaled corticosteroid therapy. All patients will be provided with an Asthma Action Plan detailing the recommended steps for daily control, managing exacerbations, and responding to an asthma attack emergency.

Measures and Other Variables

Pedersen (2013) reviews the prevalent techniques and instruments used to quantitate the degree of success in asthma control, concluding that a 'gold standard' has yet to be found. Lung function testing has its limitations, in part because it is impractical to administer in ambulatory settings, and many of the categorical tests in common use are relatively insensitive to clinically-significant changes in symptoms and exacerbation frequency. Among those recommended are the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), which has been validated for assessing clinically-significant changes in quality of life. Quality of Life for both the child and caregiver would be dependent on how well symptoms are controlled, and the resulting number of missed school days, unscheduled trips to the medical clinic, emergency department visits, and nocturnal exacerbations. For this reason, both the PAQLQ AND PACQLQ will be used to quantify the quality of life for both child and parent.

The PAQLQ is a 23-item questionnaire that queries a child between 12 and 18 years of age about their emotional state, physical activities, and asthma symptoms (Voorend-van Bergen et al., 2013). All three domains are weighted equally and a maximal score indicates an optimal quality of life. The PACQLQ is a 13-item questionnaire that queries parents about child physical activity and emotional function using a 5-item Likert scale (Juniper et al., 1996). Both instruments are self-administered and can be completed in less than 5 minutes. The PACQLQ will be administered to all caregivers, but for children under 12-years of age the PACQLQ score will be used to quantify the quality of life for both the child and caregiver.

Although forced expiratory volume in 1 second (FEV1) is considered a reliable measure of disease severity in asthma patients, the agreement between this measure and PAQLQ and PACQLQ scores is low (Pedersen, 2013; Juniper et al., 1996). Juniper and colleagues (1996) interpreted this result as consistent with FEV1 being a poor predictor of patient and caregiver quality of life and a moderately accurate measure of disease severity. Despite these significant limitations, FEV1 is probably the most widely used measure in asthma management clinical studies and has therefore become a common denominator. For this reason, FEV1 will be assessed during the study. In addition, study participants will be asked to check lung function daily using an NDD EasyOne Plus Frontline Spirometer ($575,, which will be provided to each family free of charge. Child or caregiver will record the measurements obtained, before and after inhaled corticosteroid administration, in a diary.

Another problem with current approaches to measuring disease severity in children is accurately determining the impact of symptoms on physical activities (Pedersen, 2013). A daily diary has been tried with some success (Voorend-van Bergen et al., 2013), but most studies have relied on a retrospective evaluation by study participants (Pedersen, 2013). The advances in consumer electronics over the past decade have witnessed amazing developments in personal biometric devices that can track and record physical activity. Fitbit Incorporated (2014) offers three devices that can record physical activity for days at a time, which can then be uploaded into a personal computer for analysis and permanent storage. In an effort to provide a more accurate evaluation of a child's activity during the course of the study period, all children will be provided with a Fitbit Flex (cost $99.99) free of charge. A website will also be created for uploading the data from the device through any computer connected to the internet. Children who may not have access to a computer at home will be able to upload activity data at their school, a public library, when visiting the clinic, or using a smart phone.

Children and caregivers will also be asked to track more objective measures of disease severity, including frequency and severity of exacerbations and the number of unscheduled visits to the clinic, emergency department visits, hospital admissions, missed school days, and caregiver sick days due to a sick child. All study participants will also be asked to provide demographic information during the initial consultation and study interview. The demographic information collected for the child will be age, gender, student status, smoking status, and self-reported racial/ethnic identity. The caregiver demographic information collected will be the number of parents/caregivers and parent/caregiver ages, genders, racial/ethnic identities, smoking status, educational achievements, annual family income, employment status, and histories of pulmonary disease. In addition, the caregivers will be asked to provide the size of family and whether the patient's other siblings also suffer from respiratory problems.

Study Timeline

The initial study recruitment period is expected to last approximately six months. Time zero will be the day of initial consultation, study recruitment, pretest, and general information session. Time 1 will be the day of the intensive group consultation (phase 2) and time 2 will be the day of the follow-up intensive group consultation (phase 3). Time 3 will be the day of the posttest, which will occur six months after the initial consultation. The pretest and posttest will consist of PAQLQ, PACQLQ, and lung function testing. The expected timeline for the whole study, from the start of subject recruitment to the final posttest, is expected to be one year; however, if enough subjects are not recruited into the study by the end of the initial six-month recruitment period to reach sufficient statistical power the recruitment period will be extended.

Based on the analysis by Juniper and colleagues (1996) the number of families needed for the study to achieve a statistical power of 95%, using an alpha of 0.05, is between 19 and 31. This calculation is based on a zero dropout rate over the entire six-month study period for each family. Given an expected dropout rate of at least 13% for inner city families struggling with poverty and health care access problems (Mosnaim et al., 2014), at least 70 families will be recruited into the study and randomized to either standard care or standard care plus intensive group counseling. Analysis of the data will be performed using the paired t test, two-tailed, with an alpha of 0.05. For comparisons between PAQLQ and PACQLQ subdomains, the unpaired student t test, two-tailed, will be used. Comparisons of FEV1 values will be performed using the paired student t test, two-tailed. The results of the statistical comparisons will be reported using the t-statistic, degrees of freedom, and significance value.


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