Internet-Based Home Monitoring and Education of Children With Asthma Is Comparable to Ideal Office-Based Care: Results of a 1-Year Asthma In-Home Monitoring Trial

METHODS

Children with persistent asthma were solicited for enrollment into the study via telephone (with permission from their primary care provider) and on presentation to the pediatric clinic for an asthma visit, from a population of ∼40000 military dependent children on the island of Oahu. The diagnosis of persistent asthma was based on the National Heart, Lung, and Blood Institute Expert Panel Report 2 guidelines published in 1997.¹⁶ Assignment of severity classification was made at the beginning of the study, on the basis of the severity of disease without therapy. In addition to the aforementioned factors, inclusion criteria included the following: dependent of active duty or retired US military personnel, 6 to 17 years of age, not moving from Oahu for 12 months after entry into the study, ability to receive cable modem connections in the home, willing to learn to record and to send inhaler technique and peak flow data 2 times per week, willing to attend asthma education follow-up visits either in person or electronically (virtually) at 2-week, 6-week, 3-month, and 6-month intervals after initiation into the study, willing to complete satisfaction and education surveys at the end of the study period, and willing to sign informed written consent forms. Parents were asked to give written informed consent, and patients >7 years of age were also asked to provide written informed assent. Patients underwent block randomization with a table of random numbers and were enrolled in either the “virtual” group (60 subjects) or the office-based group (60 subjects).

The initial evaluation for all patients included history, physical examination, and pulmonary function tests (spirometry). The research team solicited and enrolled all patients. A single research pediatrician (Dr Hatch-Pigott) assigned the asthma severity classification and determined the appropriate management plan by using National Heart, Lung, and Blood Institute Expert Panel Report 2 criteria, in consultation with a pediatric pulmonologist (Dr Callahan).

Office-based group patients received subsequent asthma visits in person at the pediatric clinic at Tripler Army Medical Center, with the study pediatrician and 1 of the 4 assigned nurse case managers or the pediatric clinical pharmacist case manager. Patients were treated with an ambulatory asthma clinical pathway, with 6 visits scheduled 0, 2, 6, 12, 26, and 52 weeks after enrollment. At each visit, patients and their parents received in-depth asthma education from the case manager, with specific subjects being determined by an asthma educational pathway. Office-based group patients received all of their information in person at the pediatric clinic. The virtual group received 3 in-person visits, at 0, 26, and 52 weeks, and the rest as virtual visits. Virtual visits included asthma education, a video recording of peak flow meter and inhaler use forwarded to the Web site, daily asthma diaries, and communication with the case manager electronically via the Web site. Both groups had 24-hour/7-day access to their case manager through the Internet (virtual group) and/or telephone (virtual and office-based groups). Data collection for office-based group patients began at the initial visit and ended at the last visit, which was scheduled as close to 12 months as practical for the family.

Patients in the virtual group were provided a home computer system, camera, and Internet access. On-site in-home instruction was provided by technical experts on equipment use and Web site capabilities and use. Each patient received the same models of computer and computer equipment, as well as broadband Internet access. Patients and their parents were taught how to use the equipment and how to record and to submit videos by using a computer-mounted digital video camera, to capture the patient’s peak flow meter and inhaler technique. A customized educational and monitoring Web site was developed, which allowed for secure socket layer interactive asthma education that followed the same curriculum as the office-based asthma education. The site also provided secure e-mail contact between patients and case managers, as well as the capability for digital video uploads. This interaction was deemed compliant with the current Health Insurance Portability and Accountability Act standards. Digital videos of the patients using inhaled medication and the peak flow meter were recorded and loaded to the Web site on a predetermined schedule, according to the protocol.

A detailed asthma symptom diary and quality of life survey were included on the Web site. Patients and families were instructed regarding the submission of daily symptom diary entries. This diary information was entered electronically, directly to the Web site. Videos were recorded and loaded on the site for the case manager, who scored them with standardized checklists and provided instruction through e-mail back to the patient/family. Videos were sent 2 times per week for 6 weeks and then once-weekly thereafter. Data collection for the virtual patients began when they received the computer and initial instruction and ended at the last visit, which was scheduled as close to 12 months as practical for the family.

Patients in both groups were contacted (by telephone for the office-based group and by e-mail for the virtual group) by the case manager 2 times per week for 6 weeks and once per week thereafter, to review the asthma action and home management plans, to assess the symptom diary, to remind the patient to perform and to record peak flow measurements daily in the diary, to remind the patient to complete symptom diary information every day, to answer questions, and to intervene if needed. All patients were able to contact the case manager 24 hours per day, 7 days per week, to obtain an unscheduled “sick” office visit with the pediatrician and the case manager as needed, in addition to their scheduled protocol visits.

A number of outcome parameters were assessed. In broad terms, these included measurements of adherence and disease control. We assessed selected aspects of therapeutic and diagnostic treatment regimen adherence. We defined therapeutic adherence as outcomes that assessed directly adherence to the therapeutic regimens, including controller medication use. All patient prescriptions were filled through military pharmacies by using electronic physician order entry. Computerized records of filled prescriptions were available for comparison and analysis. In addition, the number of completed dry-powder inhaler (DPI) or metered-dose inhaler with valved holding chamber (MDI-VHC) videos was compared with the number expected on the basis of the research protocol. The protocol directed patients to submit videos 2 times per week for 6 weeks and then once per week thereafter.

Diagnostic adherence focused on adherence to instructions designed to assess physiologic disease control. This included daily completion of the asthma symptom diary, electronically by virtual group patients and on paper by office-based group patients. It also included assessment of peak flow meter technique and the use and scoring of peak flow meter data submitted electronically. Virtual group patients were asked to submit digital recordings of their peak flow measurements; their actual number of submissions and their technique were compared with those expected on the basis of the research protocol. The protocol directed patients to submit a video of peak flow measurements 2 times per week for 6 weeks and then once per week thereafter. Peak flow was assessed for office-based group patients during scheduled follow-up visits.

The measures of disease control included lung function tests (spirometry performed at intake and study exit), peak flow (percentage of personal best), patient and caregiver pediatric asthma quality of life questionnaires (analyzed at intake and study exit), utilization of services (emergency department visits, hospitalizations, and unscheduled acute visits because of asthma, from our centralized medical chart database and case manager records), rescue therapy use (β-receptor agonist use and refills and use of oral prednisone rescue therapy, from computerized pharmacy records), symptom control (diary symptom score), and asthma knowledge retention (preeducation and posteducation testing). The pediatric asthma quality of life questionnaire was used with permission from Dr Elizabeth Juniper. Patient and case manager participation time was also recorded. At the completion of the study, the computers were collected from families in the virtual group.

Special emphasis was placed on the correct use of inhaled medication. MDI-VHC and DPI techniques were standardized and reinforced at every visit. Techniques were assessed at intake and at each visit and were scored with a previously described scale.¹⁵ The technique for each group using a MDI-VHC or DPI was compared at intake, at 26 weeks, and at 52 weeks.

The study pediatrician and case manager saw patients in both groups for all scheduled physician visits. The case manager recommended an appointment with the study pediatrician and case manager for patients in either group if one was needed for closer observation or intervention, as determined through telephone or e-mail communication.

Sample size was calculated by using a 2-way analysis of variance with repeated measures over the 3 time points of the pathway visits. Factor A was group, with 2 levels (traditional office-based treatment group and virtual group). Factor B was time period, with 3 levels (baseline, 26 weeks, and 52 weeks). A minimal sample size of 45 patients in each group enabled detection of an effect size of ≥20% at an α level of .05, with 84% statistical power. This sample size of 45 patients in each group would also allow detection of a difference in group means with an effect size of >30%, using a 2-tailed t test, at an α level of .05, with 80% statistical power.

Because of the mobility of our population, which was related to normal military procedures and was accentuated by deployments associated with the war in the Middle East, patient participation was calculated in patient-years. This was derived from the total number of patient days in the study divided by 365 days/year. Computerized data, including history, physical examination, and peak flow monitoring data, were collected and stored on secured government computers. All aspects of the evaluation represented the standard of care for children with asthma.

Comparisons of scores were made by using differences in the individual scores. Statistical significance was calculated by using a paired t test. The statistical significance of differences in continuous outcomes (eg, case manager and participant time) between subjects in the virtual and office-based groups was assessed with unpaired t tests or, if normality was questionable, with the nonparametric Wilcoxon rank test. For comparison of proportions with Fisher’s exact test or χ² test, a sample size of 45 in each group allowed detection of a ≥25% rate difference at an α level of .05, with statistical power of 72%.

This study protocol was approved by the human use committee at Tripler Army Medical Center. Investigators adhered to the policies for protection of human subjects prescribed in the Code of Federal Regulations, Title 45, Part 46.

RESULTS

One hundred twenty-seven patients were screened for eligibility. Of these, 7 were excluded because they were not able to meet the residency requirement of 1 year or their families were not interested in participating. Sixty were assigned randomly to the office-based group and 60 to the virtual group (Fig 1). Enrollment began in March 2003 and ended in December 2003. Patient data collection ended with the last patient’s final visit in February 2005.

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FIGURE 1

Patient enrollment and attrition.

Patients in the office-based group were slightly younger, and more had mild persistent asthma. There were more dropouts (defined as patients who were nonadherent/unable to be contacted for 8 weeks or families who notified investigators of an unanticipated military-related relocation) in the virtual group (Table 1).

Total study participation time exceeded 54 weeks for 10 patients in the virtual group and 17 patients in the office-based group, because of difficulty in scheduling the final visit. Many of the study families had a parent deploy to the war during the study year. Data were collected for all patients until the final visit was completed, so that the mean study time was 10.6 ± 3.3 months in the virtual group and 11.9 ± 2.1 month in the office-based group. Therefore, there were a total of 53 study years, 636 study months, or 19329 study days in the virtual group; there were 59.4 study years, 713 study months, or 21675 study days in the office-based group. The total study time was greater in the office-based group than in the virtual group (P < .05).

Both groups achieved excellent therapeutic adherence. Computer-accessed data on use of asthma controller medications (inhaled corticosteroids) were not different between groups, at 1 inhaler per month. Submission of inhaler technique videos was only one third of that expected from the research protocol, despite regular contact by case managers (Table 2).

Diagnostic adherence was variable. Although there was significantly greater symptom diary adherence in the virtual group (35.4%, compared with 20.8%; P < .01), no diary entry was recorded for 60% to 80% of study days. On the whole, patients completed symptom diary entries only every 2.8 days in the virtual group and 4.8 days in the office-based group. On the basis of these limited entries, patients in the virtual group recorded 61.1 ± 29.6 symptom-free days. Patients in the office-based group recorded 51.7 ± 37.6 symptom-free days. Electronic submission of peak flow measurements by patients in the virtual group was only one fourth of that directed by the protocol, despite regular contact by case managers. In both groups, peak flow technique and percentage of personal best were consistently good (Tables 3 and 4).

Disease control was excellent in both groups. Emergency department visits and hospitalizations were rare. There were only 44 unscheduled, asthma-related, office visits in the virtual group (1.2 visits per patient-year) and 47 visits in the office-based group (1.3 visits per patient-year). There were no differences in rescue therapy use between groups. There were 309 β-receptor agonist refills in the virtual group (5.8 refills or canisters per patient-year) and 323 in the office-based group (5.4 refills or canisters per patient-year). There were 133 prednisone bursts in the virtual group (2.5 bursts per patient-year) and 129 prednisone bursts in the office-based group (2.2 bursts per patient-year). Mean peak flow measurements (as percentage of personal best) were similar for the 2 groups. There were no differences between groups in forced vital capacity, forced expiratory volume in 1 second, or forced expiratory flow in midexpiratory phase at the conclusion of the study (Table 4).

Asthma knowledge scores increased significantly in both groups (10.0 ± 10.2% increase in the virtual group and 9.2 ± 7.5% increase in the office-based group). There was no difference in asthma knowledge test improvement between the groups. Pediatric asthma quality of life scores measured for caregivers improved significantly during the course of the study for both groups, from 5.7 ± 1.1 to 6.4 ± 1.0 for parents of children in the virtual group and from 5.5 ± 1.1 to 6.2 ± 0.8 for parents of children in the office-based group (P < .05, 2-way analysis of variance). There was no difference in the quality of life score changes for children in the 2 groups. Quality of life scores for either children or parents did not differ between the office-based and virtual groups (Table 5).

Mean patient scores for DPI technique improved for both office-based and virtual groups from baseline to both 26 and 52 weeks. The mean score for the office-based group improved from 82.5 ± 16% to 94.3 ± 10.9% at 26 weeks and 92.8 ± 13.9% at 52 weeks (P < .01). The mean DPI technique score for the virtual group improved from 86.7 ± 16.2% to 97 ± 9.7% at 26 weeks and 97 ± 9.2% at 52 weeks (P < .01). There was no significant change in DPI technique scores between 26 and 52 weeks for either group. There was no difference between DPI technique scores for the office-based group and the virtual group at baseline, 26 weeks, or 52 weeks (Fig 2).

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FIGURE 2

DPI technique scores.

Mean patient scores for MDI-VHC technique improved for the office-based group between baseline and 26 weeks (from 86 ± 16.6% to 93 ± 11.4%; P < .05) but returned to baseline at 52 weeks (from 86 ± 16.6% to 89 ± 15%; not significant). The mean MDI-VHC technique score for the virtual group did not change significantly between baseline and 26 weeks (87 ± 14.4% and 92 ± 12.2%, respectively; not significant) but was significantly greater at 52 weeks (94 ± 8%; P < .01). The mean MDI-VHC technique score was greater at 52 weeks for the virtual group than for the office-based group (94 ± 8% and 89 ± 15%, respectively; P < .05) (Fig 3).

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FIGURE 3

MDI-VHC technique scores. ^a Technique scores were different between groups at 52 weeks (P < .05).

DISCUSSION

Internet-based, in-home monitoring and patient asthma education were effective, compared with ideal office-based care, in this population of children of military service members. Both groups achieved excellent asthma control and had similar outcomes in what we think is the longest comparative trial of Internet-based, in-home patient monitoring and education to date.

Therapy for childhood asthma works. Patients who fail to respond to asthma therapy either do not have asthma or are not receiving the appropriate ambulatory therapy. For patients who have asthma uncomplicated by other patient factors (eg, gastroesophageal reflux) or accentuated by unhealthy living conditions (eg, constant exposure to environmental tobacco smoke), the failure to receive therapy is generally the result of nonadherence. In such cases, patients either do not receive or do not use the correct medication.¹⁷ Inadequate education of the patient, parent, and/or practitioner is inevitably a major component of the failure to receive appropriate therapy.¹⁸ This is especially true for the use of inhaled medications.

Adherence to the therapeutic plan was excellent for both groups, which likely was a major contributor to the outcomes. Pharmacy refill rates of inhaled corticosteroids reflected the use of 1 inhaler per month for patients in both the office and virtual groups, a rate consistent with that expected.

Hospitalization for treatment of asthma is the ultimate manifestation of a failure of ambulatory management for most children. At some level, it is a failure of the practitioner, patient, or parent to recognize and to respond to the child’s condition effectively. It may also represent a failure of the health care system.^19,20 Effective ambulatory treatment of asthma should therefore be expected to result in a decrease in the number of asthma-related hospitalizations and rare use of unscheduled ambulatory care in the emergency department or clinic, as it did in patients from both study groups (1 hospitalization in each group).

In addition to refill rates for controller medication, therapeutic adherence included regular assessment of DPI and MDI-VHC techniques. High scores for both groups at intake suggested that the patients and their parents were well trained in asthma management before they began the study. We have emphasized asthma management at all primary care portals for our military population on Oahu for >10 years and have witnessed a decrease in the hospitalization rate of more than one half in the same period.⁴ It was not always so. In our previous research (the Telemedicine In-Home Monitoring Evaluation Project) conducted a decade earlier in the same population, only 30% of patients who were scored after viewing a teaching videotape had scores that reflected adequate MDI-VHC technique.²¹ These data suggest that asthma management and outcomes can be improved in a population of children over time.

Children in both the virtual and office-based group who used DPI corticosteroids to control their asthma had consistently good technique throughout the yearlong study, with no significant decrease in technique. However, children who used MDI-VHC to deliver corticosteroids experienced improvement in technique in the first 26 weeks of the study. The improvement was likely related to frequent monitoring and feedback, both virtually and in person for the office-based group. Children in the office-based group experienced a decrease in their technique during the second 26 weeks, when they had only weekly telephone contact unless they were seen for an unscheduled sick visit with their provider or case manager. Both the degree of increase in MDI-VHC scores and the statistical difference between the scores of the virtual and office-based groups at 52 weeks may be of limited clinical significance. However, the difference suggests the possibility that infrequent monitoring may lead to a decline in inhaler technique over time.

As little as 5% of the drug is delivered to children using MDI-VHC under ideal conditions.^22,23 Therefore, a small decline in inhaler technique can lead to significantly diminished drug effectiveness. Poor MDI-VHC technique is a frequent reason for treatment failure in children.²⁴ There may be a role for the use of telemedicine to monitor inhaler technique in children between regular office visits or even to improve monitoring of children separate from their primary care provider or pulmonary specialist.

Patients refilled an average of 1 β-receptor agonist inhaler every other month. This is a relatively high rate for rescue medication use for children whose asthma is well controlled, although accepted guidelines suggest that occasional daily use of rescue medication may be acceptable.^16,25 It is not clear how the children used the β-receptor agonist inhalers, whether some were for school use during exercise, or even whether other family members used some of the inhalers.

Asthma action plans directed the use of orally administered corticosteroids under specific conditions of persistent symptoms, as well as the indications to seek medical therapy. Children in the virtual group had automated plans linked to their electronic, personalized, Web pages. Children in the office-based group had paper copy plans updated at each visit. There were similar numbers of oral corticosteroid rescue treatments for children in the 2 groups, which reflects the use of the asthma action plan and home corticosteroid therapy. There were also similar numbers of unscheduled asthma clinic visits and emergency department visits in the 2 groups, which reflects the equivalent clinical limitations of the asthma action plans in the 2 groups.

Children and their parents began the study with excellent knowledge of asthma. In both the virtual and office-based groups, the subjects’ asthma knowledge improved over the course of the year, which reflects the effectiveness of both electronic and in-person asthma education. Neither form of education proved superior, although it is difficult to generalize because of the high baseline asthma knowledge. The parents’ quality of life questionnaire scores improved for both groups, whereas the children’s scores did not. Perhaps the parents’ improved understanding of their child’s disease and their perception of improved asthma control and access to care contributed to the improved quality of life. Although virtual group patients were older than office-based group patients, we do not think that a 1-year age difference was a developmental factor in this population.

Despite the excellent outcomes for both groups, adherence to submission of MDI-VHC or DPI technique videos was disappointing. Only one third the number of anticipated videos were submitted to the Web site and scored. Peak flow meter video adherence was only one fourth of that expected. Similarly disappointing was the poor adherence in the use of the asthma diary by either the virtual group or the office-based group; although there were 50% more entries in the virtual asthma diaries, only one third of possible entries were completed. The relatively poor adherence with the diary explains the low number of symptom-free days in both groups; parents and children tended to remember to complete the diary during times when they were experiencing symptoms. The inconsistent adherence with the video submissions may reflect decreased interest in the Web site as the novelty waned. On average, use of the patient Web site declined steadily throughout the study period, and there was wide variation in use of the site between patients (Table 6). Poor adherence with the traditional and novel monitors of asthma management used in the 2 groups under these research conditions raises concerns about their use for clinical decision-making under normal practice conditions. It is best not to depend on a single measure for clinical decision-making and, when in doubt, to contact or to examine the child.

This study was not designed for detailed cost analysis because the economics of practice within a military setting are not always comparable to those in the civilian sector. In addition, the office-based care was designed purposely as standardized and thus more expensive than usual office care. We attempted to design the best asthma care possible to provide the most stringent comparison with in-home monitoring. There were 337 scheduled and unscheduled visits in the office-based group and 157 in the virtual group. Even in this population of children with excellent asthma control and equal access to care, parents of office-based group patients spent nearly 20 hours/year away from work caring for their children with asthma, with round-trip travel time of ∼1.5 hours for the visit and hospital encounter. Parents of virtual group patients spent one half of that.

The Asthma In-Home Monitoring project was based on the assumption that technology for in-home monitoring will become increasingly available in the decades to come. According to a Harris poll, 65% of the households in the United States are online and 44% have broadband Internet access.²⁶ It is reasonable to expect that the majority of families will have Internet access in the future and that it will become a cost-effective way to monitor children with asthma, to avoid unscheduled emergency department visits and hospitalizations. Because it allows for daily monitoring of patients, there is an opportunity to increase adherence to treatment regimens, although the reliability of these measure should be subject to the same scrutiny and even skepticism that would be used for any of the traditional ambulatory measures used to monitor patients with asthma.²⁷

Internet-based telemedicine is an effective adjunctive method to monitor children with asthma at home. Increasing availability of low-cost technology and Internet access will very likely add this capability to the armamentarium of ambulatory management tools for children with asthma. It may be of special significance for families separated from specialty care by long distances. These tools should supplement and extend the relationships between patient, parent, and provider, which remain key to the successful management of chronic diseases in childhood.