Children with Asthma

Dust Mite Intervention

Article Citation(s):
Halken S, Host A, Niklassen U, Hansen LG, Nielson F, Pedersen S, Osterballe O, Veggerby C, Poulsen LK. Effect of mattress and pillow encasings on children with asthma and house dust mite allergy. Journal of Allergy and Clinical Immunology. 2003;111:169-76.

Intervention Setting:
Participants’ homes

Target Population:
Children aged 6–15 years with well managed asthma and house dust mite (HDM) allergy.

Program Description:
This investigation aimed to determine whether use of mattress and pillow encasings resulted in effective long-term control of HDM allergen levels, thereby reducing the need for asthma medication in the children. Children were randomized to either an active treatment group that was provided mattress and pillow encasings coated with semipermeable polyurethane or a control group that received specially constructed cotton placebo mattress and pillow covers that resembled the active treatment covers. All encasings were delivered directly from the manufacturer to the patients. During the study, the encasings were to remain unwashed, and changes in the child’s mattress, bed and bedroom, as well as structural changes in the residence, were not allowed. Three children in the active group and four children in the placebo group were excluded during the study when their families could not comply with these controls or when the child did not take the medications as prescribed. A clinical evaluation with lung function measurement, adjustment of the pharmacologic treatment, and dust sampling from the child’s mattress occurred at baseline and every 3 months during the 12-month study period. At inclusion and during baseline and treatment periods, asthma medication was titrated to the lowest effective dose of inhaled steroids and B2-agonists on the basis of symptoms, need for B2-agonists, and peak flow recorded in diaries. Lung function measurements were determined using spirometry. Diaries were used to record morning and evening peak expiratory flow symptoms (symptom scores of 0–3 with 0 being no symptoms and 3 being worst case) during night and day. The number of doses of B2-agonist used on demand were recorded for 2 weeks before the visits. Forty of the 47 children using inhaled steroids used the same product during the entire study period. All children used short-acting B2-agonist as needed during the study period.

Evaluation Design:
A randomized controlled study approach was used.

Sample Size:
The study comprised 60 children with physican-diagnosed asthma, a positive skin-prick test response to HDM, a positive bronchial provocation test result with HDM allergen extract, and a measured amount of dust from the child’s mattress.

Outcome Measures/Results:
Outcome measures included reduction in HDM allergen concentrations and reductions in use of inhaled steroids. Concentrations of total HDM allergens on mattresses in the active group significantly decreased but not in the placebo group after 6 and 12 months. The daily dose of inhaled steroids (budesonide or fluticasone) was reduced by at least 50% in significantly more children in the active group than in the placebo group (73% vs. 24%, p<.01) after 12 months. The approximate 50% reduction in inhaled steroid use among the children in the active treatment group occurred without worsening in symptoms or lung function or need for rescue medication. Encasing mattresses and pillows resulted in a significant long-term reduction in both HDM allergen concentrations on mattresses and in the need for inhaled steroids in children with asthma and HDM allergy.

Materials available:
None

---

European Multi-Center Mite Allergen Sensitization Program

Article Citation(s):
Tsitoura S, Nestoridou K, Botis P, Karmaus W, Botezan C, Bojarskas J, Arshad H, Kuehr J, Forster J. Randomized trial to prevent sensitization to mite allergens in toddlers and preschoolers by allergen reduction and education. Archives of Pediatric Adolescent Medicine 2002;156:1021-27.

Associated citations:
Arshad SH, Bojarskas J, Tsitoura S, et.al. Prevention of sensitization to house dust mite by allergen avoidance in school age children: A randomized controlled study. Clinical and Experimental Allergy 2002;32(6):843-49).

Halmerbauer G, Gartner C, Schirl M, et al. Study on the prevention of allergy in children in Europe [SPACE]: allergic sensitization at 1 year of age in a controlled trial of allergen avoidance from birth. Pediatric Allergy and Immunology 2003;14:10-17.

Intervention Setting:
This multi-site community-based study was conducted in homes in four countries: England, Germany, Greece, and Lithuania.

Target Population:
Toddlers and preschoolers who initially were not sensitized to mite allergens and had at least one parent with atopic symptoms and sensitization were targeted for this study.

Program Description:
The objective of this study was to determine the effects of the reduction of mite allergen exposure on prevention of sensitization to house dust mites and development of allergic disease in toddlers and preschoolers age 1.5–5 years who were at high risk for atopy. All parents received an educational program. All were given background information about allergies and the higher risk for their child to develop an allergy. Booklets on environmental influences on children’s health and preventive recommendations were provided to the intervention group, along with additional oral explanations. A similar booklet, without information about mattress covers, was distributed to parents of the children in the control group. The intervention included providing a special dust mite-impermeable encasement for all beds in the room at home where the children in the intervention slept. Intervention group parents received extensive advice about measures to reduce dust mite allergens in the child’s room (carpet removal; hot washing of sheets, pillow, blankets, and toys; cleaning tips; ventilation; elimination of pets in the room; and avoidance of cigarette smoking). A healthcare worker visited participants’ homes at 6 months to ensure the encasements were in place and to repeat instructions for reducing house dust mite allergens. Information about the child’s atopic symptoms was obtained at 6 months in health centers. All the families in the control group in all four locations received the following common recommendations: avoid exposure to pets in bedrooms, ensure good ventilation of rooms, and avoid cigarette smoking. Likewise, information about the child’s atopic symptoms was obtained at the 6-month follow-up. After 12 months, all parents and their children were invited to participate in a follow-up examination that included a skin-prick test or immunoglobulin E (IgE) determination and a questionnaire on symptoms.

Evaluation Design:
A randomized controlled study approach was used.

Sample Size:
The study comprised 636 children with a mean age of 3.1 years. Inclusion criteria included: 1) local residence; 2) a positive parental screening questionnaire result (history of asthma, atopic eczema, or hay fever) and positive parental skin-prick test or IgE; 3) no sensitization to mite allergens at the beginning of the study; and 4) atopic manifestations, such as bronchial asthma, hay fever, or atopic eczema. Because investigators were interested in new cases of sensitization to mite allergens, they excluded all children whose skin prick tests were positive for D pteronyssinusor D farinaein the initial screening.

Outcome Measures/Results:
The primary outcome measure was sensitization to mite allergens as indicated by skin prick test or specific Ig E. Of the 330 children in the intervention group, 10 (3%) had sensitization to mite allergens compared with 20 (6.5%), in the control group, a statistically significant difference. The finding suggests that a simple program of prevention measures in childhood may reduce the risk for later development of asthma. The prevalence of atopic clinical manifestations was available for the 566 children who participated in the 12-month follow-up. Children with sensitization had a higher prevalence of symptoms of asthma and eczema (two to three times more common) and a higher prevalence of reported physicians’ diagnoses of food allergy and asthma than non-sensitized children.

---

Health Buddy Asthma Intervention

Article Citation:
Guendelman S, Meade K, Benson M, Chen YQ, Samuels S. Improving asthma outcomes and self-management behaviors of inner-city children: A randomized trial of the Health Buddy interactive device and an asthma diary. Archives of Pediatric and Adolescent Medicine 2002;156(2):114-20.

Intervention Setting:
Participants’ homes and an outpatient clinic at Children’s Hospital Oakland, Oakland, California

Target Population:
Inner-city children aged 8–16 years with persistent physician-diagnosed asthma. The child’s caregiver had to speak English, and the home had to have telephone.

Program Description:
The objective of this study was to assess the effectiveness of an interactive health communications device programmed for the management of pediatric asthma. This approach departs from conventionally delivered asthma education programs or interactive computer-based educational programs that do not rely on the interaction between the child and a health professional, educator, social worker, or other instructor. Health Buddy, programmed for the care of inner-city children with asthma, monitors asthma symptoms, quality of life, and self-care and sends information through a secured Web site to the health-care provider. The hypothesis was that by allowing children an opportunity to acquire knowledge about asthma and symptom recognition and receive immediate feedback on their decisions and behaviors, asthma symptoms among Health Buddy users would decrease. Continued use of the Health Buddy would help to increase self-care behaviors, which in turn would reduce symptoms.

All children were prescribed daily prevention medication and a quick-relief medication to use as needed. A nurse conducted a kickoff standardized teaching session. Each child received a peak flow measuring device and instruction on its use to establish personal best. They were instructed to take daily peak flow measurements and to record them in their diary. Children were then randomized and instructed how to use the assigned tracking method to record their peak flow readings and symptoms. The intervention children assigned to Health Buddy were given a demonstration on how to use the device and explained how to install it at home. The control group used an asthma diary. Each day the nurse coordinator queried to the intervention children using a standard Internet browser. The children answered the queries by pressing buttons on the device. The device automatically telephoned a data processing center at night, which processed the responses and published them to a secure website the next day. The nurse coordinator then reviewed the information. Each answer to a question received immediate feedback from the device: praise for a correct answer or encouragement to try again. Additionally, asthma facts and trivia questions that changed daily were included on Health Buddy program to pique children’s curiosity and enhance learning. The dialogs were designed for a third-grade reading level. By protocol, children had to access the device once a day. All children were asked to return for two follow-up visits at 6 and 12 weeks during which the nurse interviewed the child and delivered a standardized teaching session that reinforced peak-flow measurement compliance with meds and tracking symptoms. A physician examined each child during these follow-up visits.

Editor’s Note:
Health Buddy was developed by Health Hero Network, Mountain View, California. The device, connected to a home telephone, can be programmed to present questions and information on a screen and to record responses. Example of exchange between the child and Health Buddy: “Hi! Thanks for hanging out with your Health Buddy today. Your questions are now ready for you. Have you had any coughing or wheezing in the last day?” If the child answers “Yes”: “This could be a sign that your asthma is acting up. You may need to take your Albuterol as directed by your doctor when you are coughing and wheezing.” If the answer is “No”: “That’s great! You must be taking your preventor [sic] medicine. Did you miss out on any sports, exercise, or play yesterday because of your asthma?” If child answers “Yes”: “Sorry to hear you missed out on some fun. If your asthma acts up while doing sports, exercise, or play, please talk to your doctor about this. It is important to know what activities might trigger your asthma.” If the answer is “no”: “That is fantastic! Sports and exercise are fun and healthy.”

Evaluation Design:
A randomized controlled trial design

Sample Size:
Sixty-six participants in the intervention group, and 68 in the control group

Outcome Measures and Results:
Outcome measures included limitation to activity, peak flow reading in the red zone (<50% of the personal best) or yellow zone (50%-80% of the personal best) in the 2 weeks before the interviews, missed school days, and use of health services because of asthma in the preceding 6 weeks. Children in both arms of the study reported a decrease in asthma symptoms and decrease in peak flow readings in the yellow or red zone at 6 weeks and 12 weeks compared with baseline. Fewer children in the intervention group had peak flow readings in the yellow or red zone during the 2 weeks before the 6-week follow-up visit compared with control group children. Children in the intervention group were less likely to report limitation in activities. The odds of an urgent call for health services with Health Buddy were 0.43 of the odds of an urgent call with the asthma diary.

Availability of Protocol and Materials:
The principal investigator of the study plans to replicate this first trial in a different setting using a health-care plan and local physicians. The protocol and materials are not available for widespread distribution.

Case Study:
None

---

Inner-City Pediatric Home Intervention

Article Citation:
Carter MC, Perzanowski MS, Raymond A, Platts-Mills TA. Home intervention in the treatment of asthma among inner-city children. Journal of Allergy and Clinical Immunology 2001;108(5):732-7.

Intervention Setting:
Participants’ homes

Target Population:
Low socioeconomic, inner-city, minority children with asthma

Program Description:
This study investigated whether implementing low-cost measures for indoor allergen avoidance could reduce the number of sick days and unscheduled visits to health care facilities for asthma, and thus be considered a treatment for asthma among inner-city children. An intervention in patients’ homes was hypothesized to affect housekeeping and other aspects of asthma care. Participants were randomized to one of three groups: an active intervention group; a placebo group; or a second group. The children were tested for allergies at the end of the study, ensuring that neither the families nor the clinic staff knew which patients were allergic. Avoidance measures for the intervention group included mite-impermeable mattress and pillow covers, effective roach traps, and instructions to wash the bedding once a week in hot water. Parents in this group were also given instructions about cleaning measures to control dust mites and cockroaches. The placebo group received mite-permeable mattress and pillow covers, ineffective roach traps, and instructions to continue their normal practice of washing the bedding. Patients in the intervention and placebo groups were given a peak flow monitor, peak flow charts, and a history sheet for symptoms and medication use. They were requested to fill these in for 2 weeks after each home visit. Children in the control group continued to have their routine medical care provided at the clinic, but allergen control measures were not discussed. Only one home visit was conducted 1 year after enrollment in the study for the control group. The homes of the active and placebo group children were visited at enrollment for the initial intervention (described above) and again at 3, 8, and 12 months after enrollment to collect dust samples and inspect the house. The dust samples were sieved and assayed for dust mite, cockroach, and cat allergen. During follow-up visits mattress covers were checked, and replaced as needed, up to six cockroach traps were provided, and advice was given about their placement and about cleaning the house. The homes of children in the control group were visited for dust collection after 12 months. No intervention occurred in these homes. All the children received skin tests at the end of the study for dust mite, cockroach, cat, alternaria, rat, and mouse sensitivities. Hospital and clinic charts were examined, and the number of unscheduled visits was recorded for a 2-½ year period (1 year before enrollment and 18 months after enrollment).

Evaluation Design:
A blinded, randomized, controlled study was used that evaluated three groups of participants: an active intervention group; a placebo group; and a control group that received no intervention.

Sample Size:
A total of 104 children aged 5–16 years who had asthma and whose primary health care was provided by a clinic in Northwest Atlanta or at an urban Atlanta pediatric hospital. Children were offered enrollment when they accessed medical care.

Outcome Measures and Results:
Unscheduled clinic visits, emergency department visits, acute visits for asthma, and changes in mite and cockroach allergen levels were the measured outcomes. Acute visits for asthma among the active intervention group decreased 33% from a 15-month period (beginning 18 months before enrollment) to the end of the 15-month period after enrollment. In the placebo group, acute visits for asthma decreased 30% during the same period. By contrast, in the control group, acute visits increased by 6%. A combination of sensitization and significant exposure to dust mite or cockroach allergen was present in 59% and 43% of the study participants, respectively. A decrease in allergen concentration was judged substantial if the decrease was 70% or greater over the four visits. A substantial decrease of mite allergen occurred only in 37% of the homes with no difference between the active and placebo groups. Forty-one percent of homes in the intervention group with cockroach allergens showed significant decrease in such allergens compared with 32% of homes among the placebo group. Analyzing the outcome for children who were specifically allergic to mite or cockroach demonstrated a significant effect for decreased mite allergen but not for cockroach allergen. Children allergic to and exposed to mites who had a significant decrease in mite allergen concentration showed a statistically significant decrease in acute visits. Among the 14 children with mite allergy who had a decrease in visits, the mean change in mite allergen was –22.4% compared with +30.1% among the 15 children without a decrease in visits. This statistically significant decrease in acute visits among children with mite allergy who had a decrease in mite allergen strongly supports the relevance of allergen avoidance as an objective of treatment in this population. Although parents reported visible decrease in numbers of cockroaches, decreases in cockroach allergens were not associated with change in acute visits.

Availability of Protocol and Materials:
The protocol and materials are not available for widespread distribution.

Case Study:
None

---

Pediatric Asthma Center Program

Article Citation:
Harish ZH, Bregante AC, Morgan C, Fann CSJ, Callaghan CM, Witt MA, Levinson KA, Caspe WB. A comprehensive inner-city asthma program reduces hospital and emergency room utilization. Annals of Allergy and Asthma Immunology 2001;86:185-189.

Intervention Setting:
Pediatric asthma center in New York City

Target Population:
This research targets inner-city, pediatric asthma patients ages 2–17 and their parents/caregivers recruited from the pediatric emergency department (ED) of the Bronx Lebanon Hospital in South Bronx. The hospital serves a predominantly Hispanic (58%) and African-American (37%) population.

Program Description:
The study objective was to evaluate the efficacy of a comprehensive asthma program on ED visits and hospital admission rates in an inner-city pediatric population. The intervention consisted of three 1-hour visits conducted 2 weeks apart. The activities in the first visit included review of patient history, asthma regimen with adjustment to the National Asthma Education and Prevention Program (NAEPP) guidelines as needed, proper use of a metered dose inhaler and spacer, and a review of clinical signs of asthma. A computerized asthma education program was used to present information on asthma pathogenesis and medications. The second visit included teaching the use of a peak flow meter for patients over age 5 and instructing the children and caregivers on use of an asthma emergency plan. Visit three included skin testing for common perennial and seasonal aeroallergens. Atopic patients received detailed training in environmental control measures. Mattress and pillow encasements were provided to patients allergic to dust mites. Caregivers were encouraged to call program staff any time if symptoms did not respond to one treatment of inhaled bronchodilators. Patients were given inhaled and oral corticosteroids to be used only when instructed by the provider on call.

Evaluation Design:
The evaluation consisted of a prospective randomized controlled trial. A visiting nurse reviewed medication use and environmental allergens at home. Questionnaires were sent to each patient’s home each month asking a) “Has your child visited the ED for asthma in the last month?” – if ‘yes’ the number of times, b) “Was your child admitted to the hospital for asthma in the last month?” – if ‘yes’ the number of days, c) “Did your child miss any school days because of asthma?” Participants were awarded a lottery ticket for each completed questionnaire.

Sample Size:
Sixty children were in the treatment group, and 69 were in the control group.

Outcome Measures/Results:
Outcome measures include ED attendance and hospitalizations. In the first study year, 32 patients in the treatment group visited the ED 73 times; 46 patients in the control group visited the ED 269 times. The mean number of ED visits per patient per month was 0.1 in the treatment group and 0.326 for the control group. The decrease in ED use by treatment patients was statistically significant for 6 months of the year including the last 4 months. There were fewer admissions in the treatment group (22) than in the control group (29). In the second year of the study, the mean number of ED visits per patient per year was 0.396 for treatment group and 1.0 for the control group, a statistically significant difference. Also, in the second year, 14 (26%) of the 53 patients in the treatment group visited the ED at least once, compared with 32 (53%) of the 60 patients in the first year. In first year, 53% of the treatment group visited the ED compared with 26% in the second year, and 27% of the treatment group was admitted to the hospital in the first year compared with 11% in year 2.

Availability of Protocol/Materials:
The protocol and materials are not available for widespread distribution.

Case Study:
None

---

Sentara’s Asthma Disease Management Program

Article Citation(s):
Axelrod RC, Zimbro KS, Chetney RR, Sabol J, Ainsworth VJ. A disease management program utilizing "life coaches" for children with asthma. Journal of Clinical Outcomes Management 2001;8:38-42.

Intervention Setting:
Patients’ homes

Target Population:
Children with asthma insured by Sentara Health Management referred to the program by health plan case managers or primary care physicians. Participants had diagnosed asthma and one or more of the following: 1) one or more hospital admissions; 2) more than two emergency department visits in a 6-month period; 3) used beta-agonist reliever medications and little or no anti-inflammatory controller medications.

Program Description:
The program objective was to help children achieve and maintain control of asthma-related symptoms and to reduce resource use and associated costs. Sentara’s Asthma Disease Management Program used "life coaches" and home-based strategies to assess, teach, and monitor asthma self-management (defined as successful use of the treatment plan, successful behavior and/or lifestyle changes, and decreased use of intensive, higher-cost services) by children and their caregivers. Life coaches were registered nurses who were certified in asthma disease management and knowledgeable about community and family resources. The program provided education and support that promotes optimal independent functioning to reduce the need for more intensive and higher-cost services. Once a child was enrolled in the program, the life coach scheduled a 2–3 hour home-care visit, reviewed the child’s history, performed a physical and psychosocial assessment, evaluated past resource use, and assessed knowledge about asthma management. The life coach determined the child’s asthma severity level and set a return visit pattern with the caregiver depending on the child’s severity level and the family needs. The child was provided a peak flow meter and instructed in its use at the initial meeting in the home. After the first in-home meeting, the life coach and the primary care physician initiated the Asthma Program Treatment Plan, an asthma action plan, based on the individual needs of the child and caregiver. In later in-home meetings, the life coach taught the child and caregiver asthma self-management. Both the child and the caregiver were trained to use the Asthma Program Treatment Plan, including when to call the life coach when symptoms intensified or current treatment did not work. Frequently, the life coach could provide effective telephone intervention, preventing exacerbation of symptoms. Life coaches were available 24 hours a day, 7 days a week, to intervene and assist the child. The goal of asthma education was to increase compliance with use of appropriate asthma medications and to encourage children and their caregivers to make comprehensive behavior and lifestyle changes. After the initial visit, life coaches made routine telephone calls to monitor the children and to provide early intervention as needed to prevent complications. During the monthly follow-up calls, life coaches spoke with both the child (those aged > 6 years and older) and the caregiver to assess medication use, treatment plan results, number of days missed from school and work, and success at making home and life-style changes. Children were followed for 1 year or until self-management was achieved.

Evaluation Design:
Pre-post design

Sample Size:
A total of 294 children participated in the study

Outcome Measures/Results:
Outcome measures included medication use, hospitalizations, emergency visits, primary and specialty care visits, and costs. After enrollment, children were significantly less likely to be admitted to the hospital, a decline of 45%. Emergency department visits decreased 17% after enrollment, and primary care visits declined by 19%. No change was seen in visits to allergy or pulmonary specialists. The beta-agonists–to–anti-inflammatory medication ratio declined 20%. The average health care costs per child per month – including costs of hospital admissions, emergency visits, primary care and specialist visits, home health visits and asthma medications – declined by 25%.

Materials available:
None

---

The Canadian Asthma Primary Prevention Study

Article Citation(s):
Becker A, Watson W, Ferguson A, Dimich-Ward H, Chan-Yeung M. The Canadian Asthma Primary Prevention Study: outcomes at 2 years of age. J Allergy Clin Immunol 2004;113(4):651–6.

Intervention Setting:
Homes of study participants

Target Population:
This study focused on a cohort of infants at high-risk for development of asthma on the basis of an immediate family history of asthma. High-risk infants were defined as those with at least one first-degree relative with asthma or two first-degree relatives with other classic IgE-mediated allergic diseases as identified during the mother’s third trimester of pregnancy.

Program Description:
This study sought to determine the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants. The hypothesis was that there existed a potential for long-term modification of the infant’s risk for asthma during this small window of opportunity. After baseline assessment, a sealed envelope was opened that determined the family’s allocation to the intervention or control group. The control group did not receive specific information about intervention measures but followed the usual care recommended by their primary care physicians. Home visits were carried out during the third trimester of pregnancy, at 2 weeks, and at 4, 8, 12, 18, and 24 months after the birth of the child. Demographic and health characteristics were gathered through use of a standardized questionnaire. Home characteristics were assessed using a questionnaire and a walk-through survey.

The intervention program included the following:

1. The infant’s mattress and all mattresses and box springs in the parent’s bedroom were encased to limit exposure to house dust mites. Families were instructed to wash all bedding weekly using the hot cycle of their washing machines. Benzyl benzoate powder was applied to carpets in the infant’s bedroom, the parent’s bedroom, and the most commonly used room. Benzyl benzoate foam was applied to upholstered furniture in the most commonly used room before birth and at 4 and 8 months after birth.
2. Families were counseled to remove cats, dogs, or both from the home, or to keep pets outside the home, or at least outside the infant’s bedroom.
3. For environmental tobacco smoke (ETS), parents were counseled on smoking cessation and families were instructed to keep homes smoke free.
4. Families were encouraged to avoid daycare until after the first year of life. Nurses reinforced various avoidance measures at each home visit.
5. Mothers were encouraged to breast feed their infant for at least 4 months and for the first year if possible. Where breast-feeding was not possible, partially hydrolyzed whey formula was supplied until 12 months of age.

During each home visit dust samples were collected from the infant’s and parent’s bedroom floors and mattress and the floor and upholstered furniture in the most commonly used room. Samples were analyzed in duplicate for house dust mite and cat allergens. Allergens from these sites at each time were averaged. Each child was seen by a pediatric asthma specialist blinded to the study group and to compliance with intervention and who did not provide health care to the families. They examined the child and conducted a structured interview to record symptoms and physical findings. Allergy skin tests were conducted using house dust mite (HDM), cat, dog, cockroach, Alternaria species (fungi), cow’s milk, egg white, wheat, soy, and peanut allergens.

The intervention successfully decreased HDM exposure in the first and second year. There was significantly less cat allergen exposure in intervention homes at 2 weeks and 4 months. Mothers in the intervention group breast-fed longer and delayed introduction of solid food longer than mothers in the control group. Significantly fewer intervention group children were in daycare by 1 year of age. Finally, there was less ETS exposure in intervention homes.

Evaluation Design:
This was a prospective, prenatal, randomized, controlled clinical trial. Mothers of infants were randomized to an intervention group or a control group. The study included infants born between October 1994 and August 1996.

Sample Size:
Participants included 545 mothers of 549 high-risk infants for asthma

Outcome Measures:
Prevalence of asthma* and atopy at age 2 years in high-risk infants

Results:
At age 2 years, 19.5% of children in this high-risk cohort satisfied the criteria of having asthma, and 14.5% had positive skin test responses to at least one common allergen. At age 2 years, 16.3% of intervention group children and 23.0% of control children had asthma; 15.6% of children in the intervention group and 13.7% of control children were atopic. The intervention had a significant effect on the prevalence of asthma at age 2 years, decreasing the number of children given a diagnosis of possible and probable asthma in the intervention group (16.3%) compared with the control group (23.0%).

The main difference between the control and intervention groups was in the substantial reduction of persistent asthma, defined as asthma present at both year 1 and 2, in the intervention group (4.9%) vs. 11.3% for the control group, a 60% decrease in the intervention group. Recurrent wheeze was defined as three or more episodes of wheezing, each lasting 1 week or more. At 2 years of age, significantly fewer children had recurrent wheeze in the intervention group (1.0%) compared with control group (3.5%). The intervention had its greatest effect on recurrent wheeze with a 90% reduction in the intervention group compared with that seen in the control group at 2 years.

*Asthma was defined as the sum of children with a diagnosis of both possible asthma and probable asthma. Possible asthma was defined as at least two distinct episodes of cough each lasting for 2 or more weeks; at least two distinct episodes of wheeze, each lasting 2 or more weeks; or in the absence of a cold, at least one of the following: nocturnal cough (at least once a week) and hyperpnea-induced cough or wheeze. Probable asthma was defined as at least two distinct episodes of cough, each lasting 2 or more weeks, or at least two distinct episodes of wheeze, each lasting 1 or more weeks and one of the following: nocturnal cough lasting a week in the absence of cold, hyperpnea-induced cough or wheeze, response to treatment with B-agonist, anti-inflammatory drugs, or both.

---

The Inner-City Asthma Study-Environmental Intervention

Article Citation(s):
Morgan WJ, Crain EF, Gruchalla RS, O’Connor GT, Kattan M, Evans III R, et al. Results of a home-based environmental intervention among urban children with asthma. N Engl J Med 2004;351:1068–80.

Intervention Setting:
Study participants’ homes

Target Population:
Inner-city children with atopic asthma

Program Description:
The objective of this study was to determine whether an environmental intervention tailored to each child’s allergic sensitization and environmental risk factors could improve asthma-related outcomes. Previous studies of environmental interventions for patients with asthma have focused on a single allergen, such as dust mites or environmental tobacco smoke, rather than on the multiple exposures encountered by many urban children with asthma.

Eligibility was limited to residents of census tracts in which at least 20% of households had incomes below the federal poverty level. Eligibility criteria included at least one asthma-related hospitalization or two unscheduled, asthma-related visits to the clinic or emergency department during the previous 6 months and a positive skin test in response to at least 1 of 11 indoor allergens. A baseline clinical evaluation included questionnaires on complications related to asthma and the home environment, and skin testing was performed. A baseline home evaluation involved direct visual inspection and dust collection from the child’s bedroom. The home evaluation team collected separate, vacuumed dust samples from the child’s bedroom floor and bed. Samples were tested for dust mite, cockroach, cat, and dog allergens.

Children were randomly assigned to the control group or the intervention group by blocked randomization within a site. Families in the control group received visits only for evaluation at 6-month intervals throughout the study. The goal of the intervention was to provide the child’s caretaker with the knowledge, skills, motivation, equipment, and supplies to perform comprehensive environmental remediation. Researchers educated the family regarding the importance of the mitigation behavior and its effectiveness and modeled the targeted behavior. Caretakers performed the mitigation behavior while the environmental counselors provided feedback and encouragement.

The intervention was organized into six modules that focused on remediation of exposure to dust mites, passive smoking, cockroaches, pets, rodents, and mold. Intervention activities were tailored to each child’s skin-test-sensitization profile and environmental exposures on the basis of the caretaker’s report and the study staff’s observations during the baseline home evaluation. During the 12-month intervention, two research assistants conducted five mandatory and two optional home visits. All visits were followed by a telephone call to address any barriers to implementing the remediation plan.

During the first visit, the intervention teams taught the caretaker about the role of allergens and irritants in the child’s asthma. They also introduced the environmental intervention plan, which included the creation of an environmentally safe sleeping zone. Allergen-impermeable covers were placed on the mattress, box spring, and pillows of the child’s bed at the first visit. The teams gave families a vacuum cleaner equipped with a high-efficiency particulate air (HEPA) filter and instructed them on its use. A HEPA air purifier was set up in the child’s bedroom if the child was exposed to passive smoking, sensitized and exposed to cat or dog allergens, or sensitized to mold. Professional pest control was provided for children sensitized and exposed to cockroach allergen. Follow-up surveys of the home environment and collection of dust allergens were repeated at 6, 12, 18, and 24 months to assess changes in the home environment.

Evaluation Design:
This randomized controlled trial lasted 1 year. It included education and remediation of exposure to both allergens and environmental tobacco smoke. Home environmental exposures were assessed every 6 months and asthma-related complications were assessed every 2 months during the intervention and for 1 year after the intervention. Interviewers conducted standardized telephone interviews with each child’s primary caretaker every 2 months during the year of the intervention and the year after the intervention. They collected data on asthma symptoms, medication use, and health care use.

Sample Size:
The sample included 937 children, ages 5–11 years (mean age 7.7 years), in six major U.S. cities (Boston, Chicago, Dallas, New York City, Seattle-Tacoma, and Tucson), whose asthma had been diagnosed by a physician at research centers in those cities. Most of the children were black or of Hispanic descent, as reported by each child’s caretaker.

Outcome Measures/Results:
Children in both groups had a high prevalence of allergic sensitization to cockroach and dust-mite allergens. Exposure to tobacco smoke and airborne allergens was common. Detectable levels of cockroach allergens were found in 68.4% of bedrooms. Dust-mite allergens were found in 84.1% of bedrooms. Additionally, 76.8% of children sensitive to cockroach and 86.7% of those sensitive to dust-mite allergen had detectable levels of these allergens in their bedrooms. Home environmental interventions resulted in significantly fewer dust-mite allergens in the bed and cockroach and dust-mite allergens on the child’s bedroom floor. Those improvements remained significantly higher for the intervention group in the second year.

The primary health outcome was the maximal number of days with asthma symptoms in the 2 weeks before the telephone interview (conducted every 2 months for 2 years). Symptom days were defined as the largest value among the following three variables:

1. number of days with wheezing, tightness in the chest, or cough;
2. number of nights with disturbed sleep as a result of asthma; and
3. number of days on which the child had to slow down or discontinue play activities because of asthma.

The intervention group reported significantly fewer symptoms of asthma during the intervention year and the follow-up year. The maximal number of days with symptoms was lower in the intervention group by 0.82 day per 2-week period in the first year and 0.60 day per 2-week period in the second year. This observed reduction in symptoms translates into 34 fewer days with reported wheeze during the 2 years of the study among children in the intervention group compared with those in the control group. The interventions also helped significantly reduce disruptions of caretakers’ plans, caretakers’ and children’s lost sleep, and school days missed by the children in the intervention group. The intervention resulted in 13.6% fewer unscheduled visits for asthma per year, 19.3 fewer days with symptoms per year, and 20.7% fewer missed school days per year.

---

United Healthcare Asthma Management Program

Article Citation(s):
Georgiou A, Buchner D, Ershoff DH, Blasko KM, Goodman LV, Feigin J. The impact of a large-scale population-based asthma management program on pediatric asthma patients and their caregivers. Annals of Allergy, Asthma, and Immunology. 2003;90:308-15.

Intervention Setting:
Participants’ homes

Target Population:
Children aged 5–3 years with asthma in the United States whose families were covered by the United Health Plans were eligible for this study.

Program Description:
The objective of this study was to determine the impact of an asthma management program on pediatric patients with asthma and their caregivers over a 12-month period. In this longitudinal study, 401 randomly selected households with children with asthma completed a survey questionnaire before and after 12 months of participation in the Asthma Management Program. Information collected included daytime and nighttime asthma symptoms, functional impact of the disease, interference attributable to treatment, and impact on family activities. In addition to seeking information from caregivers on process measures (such as the use of written action plans, knowledge about asthma triggers, attack management, use of a peak flow meter), caregivers were questioned about lost work and lost school days related to their child’s asthma. Additional information about participants was supplemented by asthma-related medical care use obtained from the computerized claims database.

The Asthma Management Program interventions were tailored to each child’s asthma health risk and need as determined from medical records, filled prescriptions, and the self-reported survey. The interventions for all participants consisted of an educational booklet, asthma treatment guides and seasonal and quarterly mailings about asthma-related issues (called "educational touches"), and an asthma control kit that included a peak flow meter and an educational video. All "high-needs" asthma patients were offered one-on-one asthma education and intensive "telephonic care management" conducted by registered nurses and respiratory therapists. Telephonic care managers provided feedback to patients’ physicians when appropriate. Additionally, all high-risk members received an asthma control kit that included a peak flow meter and an educational video. All physicians were given a list of their identified asthma patients, including a medication and utilization history, and were provided copies of the NAEPP guidelines. Physicians of high-risk members were sent a letter regarding their patients’ involvement in the program and were encouraged to provide these patients with asthma action plans.

Evaluation Design:
A one-group pretest-posttest design was used with a comparison of responses to questionnaire items before and after exposure to the asthma health management program.

Sample Size:
A total of 1,003 patients were randomly sampled from a group of 3,585 patients in 17 regional health-care districts. Only 401 patients’ families completed the study.

Outcome Measures/Results:
Outcome measures related to the child’s health included daytime symptoms, nighttime symptoms, functional limitation, life interruptions resulting from treatment, impact on family activity, emergency or inpatient care for asthma, and missed school days. Caregiver measures included missed workdays because of the child’s asthma. Data indicated higher post intervention scores on all of the child’s quality of life parameters. The largest improvement was detected for nighttime symptoms (a gain of 5.8 points), the smallest change was detected for daytime symptoms (2.4 points). The proportion of children classified as having mild symptoms based on frequency of reported symptoms increased from 66.9% at baseline to 75.3% at follow-up. The percentage of patients requiring inpatient admission or emergency care decreased significantly, (9.7% vs. 5.5%) according to claims data from the baseline year and the 12-month period of intervention preceding the follow-up. The percentage of children who missed one or more school days because of asthma decreased significantly from 36% to 23%. Forty-eight (17.1%) working caregivers reported having missed 1 or more days from work during the previous 4-week period because of the child’s asthma in the preintervention period; this figure decreased to 27 (9.6%) at follow-up. Of the 48 respondents reporting 1 or more missed workdays at baseline, 38 reported no missed days at follow-up. The mean annualized number of caregiver workdays missed because of asthma care fell from 3.8 days at baseline to 1.8 days at follow-up. This computed to a baseline annual mean of 30.5 missed hours per employed primary caregiver of an child with asthma, compared with 14.4 hours per year at follow-up. The estimated indirect costs related to lost caregiver work time suggested a savings of $327.00 per employed caregiver resulting from the reduction in lost work hours.

In 2003, this program was implemented in over 30 United Healthcare Plans.

Materials available:
Materials are not available for widespread distribution.

---

Wee Wheezers at Home

Article Citation:
Brown JV, Bakeman R, Celano MP, Demi AS, Kobrynski L, Wilson SR. Home-based asthma education of young low-income children and their families. Journal of Pediatric Psychology 2002;27(8):677-88.

Intervention Setting:
The home of the patient’s caregiver

Target Population:
Inner-city African-American children aged less than 7 years from low-income families in metro Atlanta, Georgia, who made a health care visit for asthma in the preceding year, who had been prescribed medication for asthma for daily use, and whose primary caregiver spoke English.

Program Description:
Families were recruited for the study during clinic visits or by invitation letters and telephone calls. Participants were paid $75 for three study-related visits by a social worker including induction and two follow-up data collection visits. Researchers had previously adapted and piloted the Wee Wheezers education program (Wilson et. al. 1993/94) before its use with the study’s intervention group. The Wee Wheezers teaching script was modified for use with individual families, handouts were tailored to low-literacy and child audience, and the instructors delivered the content over eight sessions rather than the four used in Wee Wheezers. The revised program emphasized specific content areas, such as the developmentally appropriate level of participation of young children in asthma management.

Wee Wheezers at Home (WWH) consists of eight 90-minute education sessions provided at weekly intervals. Registered nurses conducted the course in the participants’ homes. Each session consisted of the completion of a checklist of the child’s asthma symptoms for the previous week, a discussion of the previous week’s homework assignment, an overview of the day’s session, the session topics (about 1 hour total), a review of concepts learned that day, and assignment of homework.

Session topics were:

1. Basic concepts of asthma;
2. Developmentally appropriate involvement of the child in asthma self-management, asthma cues;
3. Asthma medication and nonmedication techniques for managing asthma symptoms, working with the child to administer medicines;
4. Symptoms of acute asthma episodes, review of the action plan, children with chronic health problems;
5. Symptom prevention (trigger identification, environmental control of triggers, use of preventive medication);
6. Communication about asthma to teachers, physicians, and family members;
7. Review of asthma management concepts; and
8. Review of communication about asthma.

Caregiver and child activities included tracing the airflow on a picture of a child with the lungs drawn, identifying and coloring asthma cues and environmental triggers in a coloring book, practicing belly breathing, keeping an asthma diary, watching videos about asthma management, and practicing the use of a peak flow meter. At each session, the home visitor used a set of prepared questions based on the educational objectives to assess caregivers’ and children’s understanding of the material. Caregiver responses were used to guide the instruction in subsequent sessions. Families received printed materials and homework at each session and videotapes at some sessions. The same nurse conducted all eight sessions with a given family. The usual-care group was offered asthma training after the study was completed.

Evaluation Design:
A randomized controlled study approach was used.

Sample Size:
A total of 95 children were recruited primarily from three asthma specialty clinics.

Outcome Measures/Results:
Outcome measures included asthma symptoms, symptom-free days, acute asthma visits, and caregiver quality of life (QoL). The intervention was effective for younger children in the areas of morbidity and caregiver QoL. Researchers used the Pediatric Asthma Quality of Life Questionnaire (Juniper, 1996a) to assess QoL with three measures: a rating of how much children were bothered by asthma symptoms, the number of symptom-free days, and the number of medical visits for acute asthma exacerbations. Intervention children ages 1–3 were bothered less than usual-care children by asthma symptoms at 3- and 12-month follow-up visits. Older intervention children and the usual-care children were basically unchanged. Symptom-free days increased significantly for younger intervention children (from 37 days at baseline to 154 at 12 months) but not for older intervention children. No intervention effects were noted in the number of medical visits for acute asthma care for the 12 months preceding baseline and the period between baseline and the 12-month visit. Researchers also used the Caregiver Quality of Life (adapted from Juniper 1996b). Caregivers of younger intervention children were bothered significantly less than caregivers of usual-care children and older intervention children because of the child’s condition following the intervention. Measures of caretakers being bothered by the child’s asthma were 1=never bothered and 2=bothered 1–2 days per week or very little. The mean for caretakers of younger intervention children over time was 1.90, 1.37, and 1.17. No significant treatment effect existed in the older intervention children or usual-care children. Asthma management practices were assessed by parameters such as 1) adherence to the prescribed medical regimen for asthma on a previous day, 2) administration of asthma medication promptly with the signs of an upper respiratory infection, 3) identification of coughing or stuffy or runny nose among the earliest signs of asthma, 4) caretaker report of the frequency of 16 symptom management and prevention practices, 5) caretaker report of the level of child participation in each of the tasks required in asthma self-management. The intervention did not produce statistically significant improvement in asthma management behaviors.

Availability of Protocol/Materials:
The Wee Wheezers at Home materials are available in a program kit distributed by the Asthma and Allergy Foundation of America.

Case Study:
None

 Top of Page