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Improving Asthma Outcomes and Self-management Behaviors of Inner-city Children
A Randomized Trial of the Health Buddy Interactive Device and an Asthma Diary
Sylvia Guendelman, PhD;
Kelley Meade, MD;
Mindy Benson, PNP;
Ying Qing Chen, PhD;
Steven Samuels, PhD
Arch Pediatr Adolesc Med. 2002;156:114-120.
ABSTRACT
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Background Asthma is an important cause of morbidity, absence from school, and
use of health services among children. Computer-based educational programs
can be designed to enhance children's self-management skills and to reduce
adverse outcomes.
Objective To assess the effectiveness of an interactive device programmed for
the management of pediatric asthma.
Design A randomized controlled trial (66 participants were in the intervention
group and 68 were in the control group).
Setting Interventions conducted at home and in an outpatient hospital clinic.
Participants Inner-city children aged 8 to 16 years diagnosed as having asthma by
a physician.
Intervention An asthma self-management and education program, the Health Buddy, designed
to enable children to assess and monitor their asthma symptoms and quality
of life and to transmit this information to health care providers (physicians,
nurses, or other case managers) through a secure Web site. Control group participants
used an asthma diary.
Main Outcome Measures Any limitation in activity was the primary outcome. Secondary outcomes
included perceived asthma symptoms, absence from school, any peak flow reading
in the yellow or red zone, and use of health services.
Results After adjusting for covariates, the odds of having any limitation in
activity during the 90-day trial were significantly (P
= .03) lower for children randomized to the Health Buddy. The intervention
group also was significantly (P = .01) less likely
to report peak flow readings in the yellow or red zone or to make urgent calls
to the hospital (P = .05). Self-care behaviors, which
were important correlates of asthma outcomes, also improved far more for the
intervention group.
Conclusion Compared with the asthma diary, monitoring asthma symptoms and functional
status with the Health Buddy increases self-management skills and improves
asthma outcomes.
INTRODUCTION
ASTHMA IS an important cause of morbidity, absence from school, and
use of health services among children in the United States. Approximately
4.8 million children have asthma, and prevalence rates are increasing.1-2 More and more, asthma is being considered
an "ambulatory care sensitive condition" for which hospitalizations can be
avoided with appropriate and timely outpatient care.3(p245),4 National guidelines for clinicians in 19915 and revised in 19976
recommended the use of written asthma plans, with medications to be initiated
or increased for exacerbations to avoid unnecessary hospitalizations. Additional
preventive interventions7-9
focus on environmental modifications, such as removing dust mites or reducing
cockroach exposure, while others10-13
are directed at educating families and achieving behavioral changes and skills
management. Effective management of pediatric asthma requires involvement
of children and their families, who learn to: (1) alter the child's activities
and home environment contingent on the child's particular sensitivities; (2)
adjust the child's medications, depending on the child's physiologic state;
and (3) communicate with the child's clinician to tailor the treatment regimen.6, 14 The National Heart, Lung, and Blood
Institute (NHLBI) recommends that patients monitor their asthma with a daily
diary or a periodic self-assessment sheet before a visit to the physician
to capture their impression of whether the asthma is controlled and to assess
self-management skills.6
Several self-management programs that seek to enhance the child's and
the family's efficacy in asthma care have been developed. While education
programs delivered to parents and children by health professionals in health
care settings can improve asthma management skills, these programs often imply
large expenditures of staff time and operational challenges.14
Furthermore, life strains and health care access barriers refrain many poor
families from participating in teaching sessions and finding the time and
resources required to manage asthma.15-16
More recently, interactive computer-based educational programs, such
as Asthma Command12 and Asthma Control,14 have appeared. Unlike traditional methods, these
programs do not rely on the interaction between the child and a health professional.
Randomized trials12, 14 of these
software programs in clinic settings have demonstrated mixed results in their
ability to affect asthma management behaviors.
Another approach, the use of interactive health communication devices,
through its information and decision support, has the potential to change
behaviors and thereby improve patient quality of life and reduce the burden
of illness.17 These devices work on the premise
that the best method of affecting behaviors is to learn specific behaviors
in a safe and stimulating environment while trying them out in a real environment.18
We evaluated the efficacy of a new interactive device, the Health Buddy,
programmed for the care of inner-city children with asthma (children were
defined as those aged 8-16 years in this study). This home-based device monitors
asthma symptoms, quality of life, and self-care, and sends information through
a secured Web site to the health care provider (physicians, nurses, or other
case managers). We postulated 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.18 The continued use of
the Health Buddy would also help to increase self-care behaviors, which in
turn would reduce symptoms.
PARTICIPANTS AND METHODS
SAMPLE AND STUDY PROTOCOL
A randomized controlled trial of a computerized interactive asthma self-management
and education program, the Health Buddy, was conducted in the primary care
clinic at Children's Hospital Oakland, Oakland, Calif. This clinic is a comprehensive
pediatric health center and resident teaching facility that serves a predominantly
Medicaid-insured population. Children were eligible for inclusion in the study
if they were between the ages of 8 and 16 years, had an English-speaking caregiver,
had a telephone at home, and were diagnosed as having persistent asthma following
NHLBI clinical practice guidelines.13 Patients
with 2 or more emergency department (ED) visits and/or at least 1 inpatient
admission during the year before the study were identified for possible recruitment
through hospital administrative lists. All other children were recruited at
the time of their scheduled clinic appointment for either a health care maintenance
or an illness visit, including asthma. Patient lists were reviewed the day
before the clinic appointment, and all children with asthma as the reason
for the visit were screened for study eligibility. Potential recruits were
also referred by the attending physicians at the hospital.
Patients were excluded if they were involved in other asthma or drug
efficacy studies, if they were involved in research that required behavior
modification, or if they had mental or physical challenges that made it difficult
to use the Health Buddy. Children with comorbid conditions that could affect
their quality of life were also excluded.
Approximately 500 children aged 8 to 16 years attending the clinic had
asthma, not necessarily persistent. A screening tool that included the criteria
previously described was used, and 136 children identified as eligible were
approached for participation in the study between April 8, 1999, and July
5, 2000. Families were told that the purpose of the study was to find out
if keeping track of asthma symptoms at home would help the families and physicians
to manage the child's asthma better and that 2 methods of keeping track were
being evaluated. The nurse coordinator (M.B.) obtained informed consent for
134 children and their parents or legal guardians. Two families declined to
participate because of time constraints.
After consent was given, the nurse conducted a standardized teaching
session in which each participating child was given a peak flow measuring
device and instructed on proper technique and how to establish his or her
personal best. In addition, this teaching session also covered green-yellow-red
zone determination and the appropriate use of medications and of health care
services. Subsequently, the nurse coordinator administered the baseline questionnaire
to the child and the accompanying family member, and gave each family a $20
incentive for completing the interview. Following the interview, the nurse
opened a sealed envelope containing the treatment assignment and children
were randomized to either the intervention (n = 66) or the control (n = 68)
group and given instructions on how to use the assigned tracking method to
record their peak flow readings and symptoms. (Sample size calculations were
based on a comparison of 2 management approaches by Lieu et al,13
who observed mean numbers of episodes of children's cough and other asthma
symptoms in the previous 2 months of 2.43 for intensively treated children
and 3.08 for controls, with a pooled SD of 1.25. To detect a similar difference
with 85% power, a 2-sided 2-sample t test requires
67 subjects per group.)
INTERVENTION
The Health Buddy is a personal and interactive communication device
developed by Health Hero Network, Mountain View, Calif. The device is connected
to a home telephone and can be programmed to present questions and information
on a screen and to record responses. The nurse coordinator sends a set of
queries each day using a standard Internet browser. The patient answers the
queries, called dialogues, by pressing 1 of 4 buttons. The device automatically
telephones a data processing center at night, which processes the responses
and publishes them to a secure Web site the next day, from which the nurse
coordinator reviews the information. Three of us (S.G., K.M., and M.B.) developed
a protocol with a team of software programmers and asthma specialists at Health
Hero Network. Following the NHLBI clinical practice guidelines,6
the protocol consisted of 10 questions about asthma symptoms, peak flow readings,
use of medications and of health services, and functional status, such as
school attendance and activity limitations. Each answer to a question received
immediate feedback from the device: praise for a correct answer or encouragement
to try again. In addition to the core inmutable questions, asthma facts and
trivia questions, which changed daily, were included to peak children's curiosity
and enhance learning. The dialogues were designed for a third-grade reading
level. The following excerpt illustrates the dialogue between the child and
the Health Buddy:
Hi! Thanks for hanging out with your Health Buddy today.
Your questions are now ready for you.
Do you know how much a McDonald's hamburger cost in 1963? (Trivia)
Have you had any coughing or wheezing in the last day?
If 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 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 No:
That is fantastic! Sports and exercise are fun and healthy.
By protocol, children had to access the device once a day, preferably
at a regular time. The children were encouraged to access and interact with
the Health Buddy on their own. Parents were instructed on its use at the first
visit and requested to be available to supervise its use only when the child
indicated a need for help. Before implementation, the protocol was pilot tested
among children of comparable age to the study children, but of higher socioeconomic
status.
The comparison method for monitoring symptoms was a standard asthma
diary.13 The diary allowed patients to log
their symptoms and to monitor peak flow, medication use, and restricted activity.
Families whose children were assigned to the Health Buddy were given
a demonstration on how to use the device and explained how to install it at
home. The nurse coordinator called those families who—because they had
not installed the device properly—were not transmitting information
through the Web to review the installation instructions. No further telephone
contact was established with the participants other than to schedule follow-up
appointments. All children were asked to return for 2 follow-up visits at
6 and 12 weeks. At each follow-up visit, families were interviewed by the
nurse coordinator and given a standardized teaching session that reinforced
peak flow measurement, compliance with medicines, and tracking of symptoms.
Families received a participation incentive, and children were asked to hand
in their health diaries. They were also examined by a physician. Medical management
remained at the discretion of the physician and followed NHLBI guidelines.
Because all participants were diagnosed as having persistent asthma before
the study, they were prescribed a daily prevention medication and a quick-relief
medication to use as needed, and were requested to measure peak flows. Treatment
regimens were kept constant between visits and changed at the follow-up visits
only if there was a significant deterioration or improvement in asthma symptoms.
MEASURES
The measures for this study were obtained from the interviews that the
nurse coordinator conducted with the child and the primary caregiver at each
visit. The questionnaire was designed according to well-validated instruments.19-21 The self-reported
information at the follow-up visits was validated against the nurse's knowledge
of the patients and assisted by a medical record review at the time of the
visit.
The primary outcome measure was limitation in activity, which referred
to the occurrence of restricted physical activity, such as exercise or play,
due to asthma. This measure has been a valid indicator of functional status
in other studies.19
Secondary outcome measures consisted of other self-reported perceived
asthma symptoms in the 14 days before the interview, any missed school days
because of asthma in the 6 weeks before the interview, any peak flow reading
in the red or yellow zone in the 14 days before the interview, and use of
health services because of asthma in the past 6 weeks. The symptom indicators
included the occurrence of chest tightness, coughing, shortness of breath
or wheezing, and trouble sleeping at night as a result of coughing or wheezing.
Peak flow readings in the yellow or red zone were based on the best of 3 readings
obtained by the patient on the peak flow meter, a measure of the maximum flow
rate that can be generated during a forced expiratory maneuver. Although peak
flow meters are criticized because they tend to measure the amount of obstruction
in the larger airways only, and often compliance with its use is low, they
provide the only readily available objective means of patient monitoring at
home.22-23 Peak flow readings
in the yellow zone (50%-80% of the personal best) indicated that the child's
asthma was not under sufficient control and required additional medication.
Readings in the red zone (<50% of the personal best) signaled a severe
asthma exacerbation. Children were instructed to take daily peak flow measurements
and to record them in their diary.
Use of health services was measured by the presence of hospital admissions,
ED visits, or urgent calls to the hospital.
Self-care behaviors assessed the degree of compliance with prescribed
medications and with the use of the Health Buddy or asthma diary, as appraised
by the main caregiver. These self-care behaviors, along with the asthma outcomes
and demographic characteristics, were assessed through a 30-minute questionnaire
consisting predominantly of close-ended questions. The questionnaires were
administered at baseline and at the 2 follow-up visits at 6 and 12 weeks.
In addition, tracking with the Health Buddy or asthma diary was recorded by
each child. At baseline, children were classified according to NHLBI practice
guidelines into mild persistent, moderate persistent, or severe persistent
asthmatic categories. These levels of asthma severity are based on symptom
frequency and severity, exercise tolerance, ED visits, hospitalizations, and
current medications.13
DATA ANALYSIS
 2 Tests, Fisher exact tests, and 2-sample t tests were used to compare the 2 study groups for demographic characteristics
(at baseline), asthma outcomes, and self-care behaviors at baseline and at
the 2 follow-up visits. Logistic regression was used to model the main effects
of treatment. The results with P .05 were justified
as significant. Because observations at the 2 follow-up visits were not independent,
the technique of generalized estimating equations24
was used to estimate treatment effects. For each outcome, the baseline results,
the asthma severity score, and the visit were included as covariates. The
effect is presented as the intervention odds ratio, which is the ratio of
odds of an outcome in the Health Buddy group to the odds of the same outcome
in the asthma diary group, adjusted for visit, baseline responses, and asthma
severity. A generalized estimating equation was also used to evaluate the
effects of self-care behaviors on selected asthma outcomes, adjusted for visit,
other behaviors, and treatment effects. Interaction terms between treatment
and time were evaluated for all outcomes. Missing data were handled by assuming
missing at random.25
RESULTS
The Health Buddy and asthma diary groups had similar demographic characteristics,
illness history, home environment, and use of health services at baseline,
as expected from the random assignment (Table 1). Follow-up of participants occurred similarly across all
4 seasons in the 2 groups. Ninety-six percent of the participants (63 in the
Health Buddy group and 65 in the asthma diary group) returned for the first
follow-up visit at 6 weeks and 91% (62 in the Health Buddy group and 60 in
the asthma diary group) returned for the follow-up visit at 12 weeks. Reasons
for dropping out of the study included moving out of the area (n = 3) or life
crises experiences (n = 4). Five families who dropped out were unavailable
for contact. Baseline characteristics of children who did and did not complete
the trial did not differ.
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Table 1. Baseline Characteristics of Children Enrolled in the Study*
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Children in both arms of the study reported a decrease in asthma symptoms
and a decrease in peak flow readings in the yellow or red zone at 6 and 12
weeks compared with baseline (Table 2). Although almost half of the children did not use a peak flow device at baseline,
at the 6-week follow-up visit, 85% of the participants reported that they
used it. Significantly fewer children randomized to the Health Buddy had peak
flow readings in the yellow or red zone during the 14 days before the 6-week
follow-up visit compared with children randomized to the asthma diary (P = .02).
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Table 2. Trial Period Comparisons of Asthma Symptoms
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After adjusting for time and baseline covariates, children in the Health
Buddy group were less likely to report limitation in activities. Furthermore,
the odds of having peak flow readings in the yellow or red zone were significantly
lower for children randomized to the Health Buddy.
The use of health services did not vary significantly between the 2
groups, except for urgent calls. The odds of an urgent call with the Health
Buddy was 0.43 of the odds of an urgent call with the asthma diary, after
adjusting for time and baseline covariates (Table 3). No significant interactions between treatment and time
were found for any outcome.
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Table 3. Trial Period Comparisons of Use of Health Services
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For self-care behaviors, at 12 weeks children with the Health Buddy
were significantly more likely to take asthma medicines without reminders
(P = .04) and to use the Health Buddy with few or
no reminders (P = .001) (Table 4). These self-care behaviors were significant correlates
of asthma outcomes after adjusting for treatment effects, time, and other
self-care behaviors (data not shown). Children who always used the Health
Buddy or the asthma diary without a reminder were significantly less likely
to report coughing or wheezing (odds ratio, 0.70; 95% confidence interval,
0.50-0.99) and had a lower probability of having a limitation in activities
(odds ratio, 0.70; 95% confidence interval, 0.50-0.90).
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Table 4. Trial Period Comparisons of Self-management Behaviors*
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On average, during the 90-day trial period, 77% of the children used
their tracking system 3 days a week or more (59 [89%] of the 66 children in
the Health Buddy group vs 44 [65%] of the 68 children in the asthma diary
group; P<.001). The daily compliance rates declined
as time progressed for both treatment arms, but the decline was faster in
the early stages of the intervention for the asthma diary group (P = .0004, data not shown). An analysis of time effects adjusted for
treatment assignment (data not shown) indicated that asthma symptoms and use
of health services declined markedly from one visit to the next for both groups.
We found no strong indication that the correlation between asthma diary
and Health Buddy responses and interview responses differed between the 2
study groups. However, responses across visits seemed to be more stable for
the Health Buddy group.
COMMENT
This randomized trial conducted in an inner-city ambulatory care clinic
assessed the efficacy of the Health Buddy for self-management of persistent
asthma in children. We compared the effects of this device, which is a nonintrusive
interactive system that linked patients at home to the nurse coordinator,
with the effects of the standard asthma diary.
One of the goals of asthma control is to be free of activity limitation.
Children randomized to the Health Buddy had 48% lower odds of reporting a
limitation in activity after adjusting for baseline response, asthma severity,
and time. Children randomized to the Health Buddy also had significantly lower
odds of reporting a peak flow reading below 80% of their personal best (red
or yellow zone) after adjusting for covariates. Despite missing data for this
outcome, especially among children in the asthma diary group, the higher rate
of children with peak flow readings remaining in the green zone among Health
Buddy users is an indicator of improved control of asthma symptoms and improved
response to anti-inflammatory therapy. Spirometry was not available for the
study.
The percentage of children randomized to the Health Buddy who used the
device was, until near the end of the study, much larger than the percentage
of children who kept diaries. This leads to the following question: Was self-monitoring,
per se, associated with improved outcomes? The analysis of this question does
not benefit from randomization. Children who used the Health Buddy or asthma
diaries with few or no reminders were far less likely to report coughing or
wheezing and to have a limitation in activities.
Several children reported after the trial that they liked the Health
Buddy because it was fun and it reminded them to take their medicines. In
contrast, several children who received the asthma diary reported that they
either lost it or forgot to log information in it. Many children who kept
diaries reported that they had forgotten to take their medicines. These results
occurred despite the decline in Health Buddy use and suggest that children
with the Health Buddy device learned management skills that helped them to
comply with their treatment and medication regimens.
The short duration of the trial and the small sample size did not yield
marked group differences in the occurrence of ED visits or hospital admissions.
However, after adjusting for time, asthma severity, and urgent calls before
the baseline interview, the risk of urgent calls was twice as high for children
assigned to the asthma diary group. This finding would suggest a weaker autonomy
in the management of asthma for the child and the family assigned to the control
arm of the study.
Despite the marked advantages of the Health Buddy monitoring system
over the standard asthma diary, use in both groups declined as children approached
the end of the trial. These declines probably reflect the anticipated end
of the study, the lack of perceived additional benefit of monitoring, and,
for Health Buddy users, saturation with the educational messages. This trend
would suggest that the benefits of self-monitoring with a device like the
Health Buddy might be especially strong at critical care management times
(eg, at the start of care for asthma or after an acute asthma exacerbation,
an ED visit, a hospitalization, or a step up in severity class).
Although asthma symptoms declined more for the Health Buddy group, symptoms
also declined for the asthma diary group. This decline may have partly resulted
from the consistent standardized asthma education given to children in both
arms of the study and the availability of the nurse coordinator, which was
a new intervention to the clinic. Furthermore, because this intervention took
place shortly after dissemination of the revised NHLBI asthma guidelines,
the findings may reflect enhanced care by the hospital staff resulting from
adherence to these guidelines.
The results must be interpreted with caution given the study limitations.
Despite the attempts by the nurse coordinator to check the self-reported data
at each interview, there may have been some case ascertainment bias. Furthermore,
children in the asthma diary group who filled out diaries retrospectively
may have overstated compliance. In addition, some of the results were leaning
toward significance, suggesting that there might have been a lack of power
to detect significant differences because of a small sample size. Further
research is needed to assess the effects of this device on the behavior of
health care providers. At the time of the study, implementation graphs and
other data outputs were not readily or consistently available for providers.
The system now has the capacity to summarize longitudinally patient data on
symptoms, health behaviors, and knowledge levels. Research is also warranted
to evaluate individual differences in self-management skills, outcomes, and
saturation points associated with Health Buddy use among inner-city children.
A longer follow-up study could determine whether changes in asthma self-care
behaviors and symptoms persist over time. The cost of using the Health Buddy
technology and service consists of one-time implementation fees and patient
activation fees, which vary by disease and by patient volume. The average
monthly cost per patient ranges from $20 to $45. Additional costs involve
the case manager and depend on caseload. A cost-effectiveness analysis focusing
on ED visits, hospitalizations, and other burdens to the health care system
would help to determine if the extra expense of the computer telephone system
is worth the observed improvement vs close follow-up by the nurse case manager
alone. Nevertheless, the significant group effects in self-care behaviors
and asthma outcomes found with the Health Buddy suggest that such easy-to-use
devices empower children to provide more of their own care, while perhaps
reducing the burden of illness on the family and on the health care system.
| What This Study Adds
Several programs that seek to enhance efficacy in self-management have
been developed in asthma care. Randomized trials of computer-based educational
programs conducted in clinic settings have demonstrated mixed results in their
ability to affect asthma management behaviors. We evaluated the efficacy of
a new home-based interactive health communication device, the Health Buddy,
that was designed to enable children to assess and monitor their asthma symptoms
and quality of life and to transmit this information to a case manager through
a secure Web site. This study presents the results of a randomized, controlled,
90-day clinical trial of inner-city children with persistent asthma. Compared
with children assigned to an asthma diary, children randomized to the Health
Buddy were more likely to improve self-care behaviors and to reduce asthma
symptoms, while making fewer urgent calls to the hospital, after adjusting
for other factors. Easy-to-use Web-based devices such as the Health Buddy
may be useful tools to empower children to provide their own care while reducing
asthma symptoms and health care use in pediatric settings.
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AUTHOR INFORMATION
Accepted for publication October 18, 2001.
This study was supported in part by an unrestricted educational grant
from Health Management Services, Merck & Co, Inc, Whitehouse Station,
NJ.
We thank Scott Hambly and Mara Sanderson for their clerical support.
Corresponding author and reprints: Sylvia Guendelman, PhD, Division
of Health Policy and Management, University of California, Berkeley, 404 Earl
Warren Hall, 7360, Berkeley, CA 94720-7360 (e-mail: sylviag{at}uclink4.berkeley.edu).
From the Maternal and Child Health Program (Drs Guendelman and Samuels),
the Division of Health Policy and Management (Dr Guendelman), and the Division
of Biostatistics (Dr Chen), School of Public Health, University of California,
Berkeley; and Ambulatory Services, Children's Hospital Oakland, Oakland, Calif
(Dr Meade and Ms Benson).
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