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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive, focusing on prevention and control, rather than reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning signs of asthma attacks in order to prompt appropriate interventions and timely visits to Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a preliminary study of the paper-based version of the AT, frequent users had significantly fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot testing revealed that the tool was useful in helping them manage their child's asthma and were interested in assessing the tool's effectiveness and in identifying and addressing barriers to their sustained use of the e-AT.
Improving asthma control in children will be facilitated by broad e-AT dissemination, and by identifying and addressing critical factors that contribute to parent sustained participation in self-management. The investigators propose to assess the effectiveness of the new ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing barriers and facilitators of sustained parent use. The investigators will engage parents throughout this study to identify and address themes that matter to them. The target population is children with persistent asthma, ages 2-17 years. The investigators have engaged 10 parents since conception of this project, from the planning to design and validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and facilitated discussions to inform the development of this proposal including research objectives and outcome measures. In addition, the investigators have recruited other key stakeholders for whom the results of the research will be relevant.
Through the following specific aims, the investigators will:
Aim 1: Assess the effectiveness of the new ambulatory care model, by comparing outcomes at the 1.a. child (child's quality of life (QOL), asthma control, missed school days), 1.b.parent (satisfaction, parent missed work days) and 1.c. clinic (ED/hospital visits) levels, between clinics randomly assigned to either the standard e-AT intervention vs. intensive e-AT intervention. 1.d. Use non randomized comparisons to determine the effectiveness of the e-AT relative to a control group (usual care) in which the e-AT was not used
Aim 2: Assess the association of QOL, asthma control, and ED/hospital admissions with the prior frequency of e-AT use and assess if the association differs between parent subgroups (high vs. low literacy, Medicaid vs. private insurance, and frequent vs. less frequent e-AT users).
Aim 3: Determine the association of demographic, socio-economic, behavioral, and technology factors with sustained parent participation in asthma self-management.
The outcome measures are:
Primary Outcome:
Child quality of life (QOL)
Secondary Outcomes:
Child asthma control
Child interrupted/missed school days
Child use of oral steroids (surrogate measure of an asthma exacerbation)
Parent satisfaction with care
Parent interruption/missed work days
Clinics: ED/Hospital admissions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard e-AT Intervention | Experimental | Patients in Standard e-AT or standard intervention group will receive a daily (if a participant forgets to complete his/her weekly assessment) email and text reminders with a link to the e-AT website to help patient/parent participants to comply with their weekly assessment of patient's level of asthma control. Note: patient/parent participants are required to complete their asthma control assessment 1x/week. The e-AT is now set up to send a weekly reminder to participants with a link to the website. If a participant does not complete an assessment within a week of the last assessment, the reminder will be sent daily until the patient/parent complies and the system resets to weekly. |
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| Intensive e-AT Intervention | Experimental | Participants in the intensive e-AT or adherence support intervention will receive everything as those in Standard Intervention. In addition, they will see a progress bar display, which adds 25 points each time they complete an assessment. When this bar reaches 100 points, a pop-up message with fireworks will appear to congratulate them about the milestone. The progress bar resets to zero after it reaches 100 points. Participants will also see a leader board allowing them to compare themselves with the 5 best users to increase compliance. |
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| Usual Care (Non-Randomized Cohort) | No Intervention | Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Standard vs Intensive e-AT Intervention | Other | Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions | Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning. | Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention. |
| Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning. | Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Satisfaction With Care, Standard vs Intensive | Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being "Very Dissatisfied" and 5 "Very Satisfied". | Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions |
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Facility Eligibility
Clinics are eligible for participation if they meet the following criteria:
Patient Inclusion Criteria
Patient Exclusion Criteria:
As this is a pragmatic trial assessing evidence of the e-AT in a real clinical environment, no patients will be excluded as long as they meet inclusion criteria. However, during the time of analysis, we will conduct a sub-analysis, comparing the effectiveness of the new care model among patients with or without co-morbid conditions that may affect measured asthma outcomes. These include patients with a history or increased risk of pulmonary disease (cystic fibrosis, bronco-pulmonary dysplasia, aspiration pneumonia, severe Cerebral Palsy (CP) with aspiration risk, technology dependency (gastrostomy tube, tracheostomy), history of congenital heart disease requiring surgical correction or with complicating congestive heart failure requiring medical management, immunodeficiency (including patients on immunosuppressants), and malignancies.
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| Name | Affiliation | Role |
|---|---|---|
| Flory Nkoy, MD, MS, MPH | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | CDC. National Health Interview Survey (NHIS) Data2009. http://www.cdc.gov/asthma/nhis/09/data.htm | ||
| 21355352 | Background | Akinbami LJ, Moorman JE, Liu X. Asthma prevalence, health care use, and mortality: United States, 2005-2009. Natl Health Stat Report. 2011 Jan 12;(32):1-14. | |
| Background | CDC. Healthy Youth! Health Topics, Asthma2009. | ||
| Background | Wessel L, Spain J. The Chronic Care Model: A Collaborative Approach to Preventing and Treating Asthma in Infants and Young Children. January 2005. EJ847179 | ||
| Background |
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We can only share completely de-identified data. Request can be sent to my email: flory.nkoy@hsc.utah.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard e-Asthma Tracker (e-AT) Intervention | Patients in Standard e-AT intervention group will be using the standard version of e-AT |
| FG001 | Intensive e-Asthma Tracker (e-AT) Intervention | Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users. |
| FG002 | Usual Care (Non-Randomized Cohort) | Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard e-AT Intervention | Patients in Standard e-AT intervention group will be using the standard version of e-AT. |
| BG001 | Intensive e-AT Intervention | Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions | Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning. | We enrolled 327, 2 clinics with only 1 patient enrolled were excluded, leaving 325 patients. Of 325, 7 did not provide baselines and were excluded, leaving 318 (261 standard vs. 57 intensive) participants. Row numbers differ due to different number of participants completing 3, 6, and 12 months follow-ups, due to withdrawal and loss to follow-up. | Posted | Mean | Standard Error | Units on a scale | Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention. |
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This study is a minimal risk study, with patients logging in to a secure web-based self-management tool and answering questions about their asthma symptoms. The only intervention in the study was to have patients use this tool to manage asthma. No serious adverse risk is involved in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard e-AT Intervention | Patients in Standard e-AT intervention group will be using the standard version of e-AT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Flory Nkoy | University of Utah | 801-662-3660 | flory.nkoy@hsc.utah.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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We initially enrolled 327 randomized (at the clinic level) participants who received the e-AT interventions overall, including 267 participants receiving the standard intervention and 60 receiving the intensive intervention. We also included another set of 599 non-randomized matched controls of patients with persistent asthma retrieved electronically from non-participating clinics. This is why we stated that 926 subjects (327+599) overall were included.
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| Child Interrupted/Missed School Days, Standard vs Intensive | Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. | Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups |
| Parent Interrupted/Missed Work Days, Standard vs Intensive | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. | Interrupted/missed work days were measured baseline 3, 6, and 12 months |
| Asthma Control Change, Standard vs Intensive | Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4. | Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive |
| Emergency Department (ED)/Hospitalization, Standard vs Intensive | ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention | Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use |
| Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) | Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied. | Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores |
| Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months. | baseline ACT scores were compared to quarters 1, 2, 3, 4. |
| Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study). | 1 year |
| Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study. | 1 year |
| ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) | ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered. | 1 year |
| Use of Oral Steroid, Overall | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall. | 1 year |
| ED/Hospital Admission, Early vs. Late Patients | ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. | 1 year following e-AT use for early and late starting patients |
| Oral Steroid Use, Early vs. Late Patients | Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. | 1 year |
| ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) | ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants. | 3-month period prior to the late clinics starting the e-AT |
| Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants | 3 month period prior to the late clinics starting the e-AT |
| ED/Hospital Admissions, e-AT vs Usual Care | Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. | 1 year |
| Oral Steroid Use, e-AT vs Usual Care | Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. | 1 year |
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| 12106617 | Background | Perneger TV, Sudre P, Muntner P, Uldry C, Courteheuse C, Naef AF, Jacquemet S, Nicod L, Rochat T, Assal JP. Effect of patient education on self-management skills and health status in patients with asthma: a randomized trial. Am J Med. 2002 Jul;113(1):7-14. doi: 10.1016/s0002-9343(02)01136-1. |
| 21646583 | Background | Rhee H, Belyea MJ, Hunt JF, Brasch J. Effects of a peer-led asthma self-management program for adolescents. Arch Pediatr Adolesc Med. 2011 Jun;165(6):513-9. doi: 10.1001/archpediatrics.2011.79. |
| 11814370 | Background | 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. Arch Pediatr Adolesc Med. 2002 Feb;156(2):114-20. doi: 10.1001/archpedi.156.2.114. |
| 11493372 | Background | Bheekie A, Syce JA, Weinberg EG. Peak expiratory flow rate and symptom self-monitoring of asthma initiated from community pharmacies. J Clin Pharm Ther. 2001 Aug;26(4):287-96. doi: 10.1046/j.1365-2710.2001.00361.x. |
| 16847876 | Background | Thompson R, Delfino RJ, Tjoa T, Nussbaum E, Cooper D. Evaluation of daily home spirometry for school children with asthma: new insights. Pediatr Pulmonol. 2006 Sep;41(9):819-28. doi: 10.1002/ppul.20449. |
| 17332210 | Background | Chan DS, Callahan CW, Hatch-Pigott VB, Lawless A, Proffitt HL, Manning NE, Schweikert M, Malone FJ. 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. Pediatrics. 2007 Mar;119(3):569-78. doi: 10.1542/peds.2006-1884. |
| 18931330 | Background | de Jongste JC, Carraro S, Hop WC; CHARISM Study Group; Baraldi E. Daily telemonitoring of exhaled nitric oxide and symptoms in the treatment of childhood asthma. Am J Respir Crit Care Med. 2009 Jan 15;179(2):93-7. doi: 10.1164/rccm.200807-1010OC. Epub 2008 Oct 17. |
| 16585298 | Background | McPherson AC, Glazebrook C, Forster D, James C, Smyth A. A randomized, controlled trial of an interactive educational computer package for children with asthma. Pediatrics. 2006 Apr;117(4):1046-54. doi: 10.1542/peds.2005-0666. |
| 19126178 | Background | Willems DC, Joore MA, Hendriks JJ, Nieman FH, Severens JL, Wouters EF. The effectiveness of nurse-led telemonitoring of asthma: results of a randomized controlled trial. J Eval Clin Pract. 2008 Aug;14(4):600-9. doi: 10.1111/j.1365-2753.2007.00936.x. Epub 2008 Jul 9. |
| 17603828 | Background | Jan RL, Wang JY, Huang MC, Tseng SM, Su HJ, Liu LF. An internet-based interactive telemonitoring system for improving childhood asthma outcomes in Taiwan. Telemed J E Health. 2007 Jun;13(3):257-68. doi: 10.1089/tmj.2006.0053. |
| 17290041 | Background | Joseph CL, Peterson E, Havstad S, Johnson CC, Hoerauf S, Stringer S, Gibson-Scipio W, Ownby DR, Elston-Lafata J, Pallonen U, Strecher V; Asthma in Adolescents Research Team. A web-based, tailored asthma management program for urban African-American high school students. Am J Respir Crit Care Med. 2007 May 1;175(9):888-95. doi: 10.1164/rccm.200608-1244OC. Epub 2007 Feb 8. |
| Background | NHLBI. So You Have Asthma. 2007(NIH Publication No. 07-5248). https://www.nhlbi.nih.gov/files/docs/public/lung/have_asthma.pdf. |
| 8040154 | Background | Cuijpers CE, Wesseling GJ, Swaen GM, Sturmans F, Wouters EF. Asthma-related symptoms and lung function in primary school children. J Asthma. 1994;31(4):301-12. doi: 10.3109/02770909409089477. |
| 21261742 | Background | Davis KJ, Disantostefano R, Peden DB. Is Johnny wheezing? Parent-child agreement in the Childhood Asthma in America survey. Pediatr Allergy Immunol. 2011 Feb;22(1 Pt 1):31-5. doi: 10.1111/j.1399-3038.2010.01016.x. Epub 2010 Sep 9. |
| 16705016 | Background | Halterman JS, Yoos HL, Kitzman H, Anson E, Sidora-Arcoleo K, McMullen A. Symptom reporting in childhood asthma: a comparison of assessment methods. Arch Dis Child. 2006 Sep;91(9):766-70. doi: 10.1136/adc.2006.096123. Epub 2006 May 16. |
| 16717140 | Background | McQuaid EL, Koinis Mitchell D, Walders N, Nassau JH, Kopel SJ, Klein RB, Wamboldt MZ, Fritz GK. Pediatric asthma morbidity: the importance of symptom perception and family response to symptoms. J Pediatr Psychol. 2007 Mar;32(2):167-77. doi: 10.1093/jpepsy/jsj112. Epub 2006 May 22. |
| 18573649 | Background | Hagmolen Of Ten Have W, van den Berg NJ, van der Palen J, van Aalderen WM, Bindels PJ. Limitations of questioning asthma to assess asthma control in general practice. Respir Med. 2008 Aug;102(8):1153-8. doi: 10.1016/j.rmed.2008.03.008. Epub 2008 Jun 24. |
| 11372088 | Background | Bridge PD, McKenzie SA. Bronchodilator responsiveness testing in young children. Arch Dis Child. 2001 Jun;84(6):525. doi: 10.1136/adc.84.6.525n. No abstract available. |
| Background | NHLBI-EPR-3. Guidelines for the diagnosis ane management of asthma. Periodic Assessment and Monitoring: Essential for Asthma Management. 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthsumm.pdf |
| 8745846 | Background | Tirimanna PR, Den Otter JJ, Van Schayck CP, Van Herwaarden CL, Folgering H, Van Weel C. Evaluation of the suitability of weekly peak expiratory flow rate measurements in monitoring annual decline in lung function among patients with asthma and chronic bronchitis. Br J Gen Pract. 1996 Jan;46(402):15-8. |
| 7886646 | Background | Frischer T, Meinert R, Urbanek R, Kuehr J. Variability of peak expiratory flow rate in children: short and long term reproducibility. Thorax. 1995 Jan;50(1):35-9. doi: 10.1136/thx.50.1.35. |
| 11502647 | Background | Goldberg S, Springer C, Avital A, Godfrey S, Bar-Yishay E. Can peak expiratory flow measurements estimate small airway function in asthmatic children? Chest. 2001 Aug;120(2):482-8. doi: 10.1378/chest.120.2.482. |
| 17353040 | Background | Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13. |
| 14713908 | Background | Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008. |
| 11679021 | Background | McGrath AM, Gardner DM, McCormack J. Is home peak expiratory flow monitoring effective for controlling asthma symptoms? J Clin Pharm Ther. 2001 Oct;26(5):311-7. doi: 10.1046/j.1365-2710.2001.00374.x. |
| 20530041 | Background | Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma Control Questionnaire in children: validation, measurement properties, interpretation. Eur Respir J. 2010 Dec;36(6):1410-6. doi: 10.1183/09031936.00117509. Epub 2010 Jun 7. |
| 19047258 | Background | Kattan M. Quality of inpatient care for asthma: challenges and opportunities. Pediatrics. 2008 Dec;122(6):1369-70. doi: 10.1542/peds.2008-2787. No abstract available. |
| BG002 | Usual Care (Non-Randomized Cohort) | Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG000 | Standard e-AT Intervention | Patients in Standard e-AT intervention group using the standard version of e-AT. |
| OG001 | Intensive e-AT Intervention | Participants in the intensive e-AT intervention group using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users. |
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| Primary | Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning. | The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to withdrawal from the study or loss to follow-up. | Posted | Mean | Standard Deviation | units (points) on a scale, range 0-100 | Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL |
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| Secondary | Parent Satisfaction With Care, Standard vs Intensive | Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being "Very Dissatisfied" and 5 "Very Satisfied". | We had 261 in Standard e-AT and 57 in Intensive e-AT who completed baseline survey, and 166 in Standard e-AT and 42 in Intensive e-AT completed the 12 Months Follow-up Survey. This is due to participant withdrawal and loss to follow-up. | Posted | Mean | 95% Confidence Interval | units (points) on a scale (from 1-5) | Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions |
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| Secondary | Child Interrupted/Missed School Days, Standard vs Intensive | Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. | We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions | Posted | Number | Number of interrupted/missed school days | Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups |
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| Secondary | Parent Interrupted/Missed Work Days, Standard vs Intensive | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. | We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions | Posted | Number | Number of interrupted/missed work days | Interrupted/missed work days were measured baseline 3, 6, and 12 months |
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| Secondary | Asthma Control Change, Standard vs Intensive | Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4. | Posted | Mean | Standard Error | mean score (points) change | Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive |
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| Secondary | Emergency Department (ED)/Hospitalization, Standard vs Intensive | ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention | Number of pre- and post e-AT ED and hospital admissions were compared between standard and intensive groups. | Posted | Number | Number of ED/hospital admissions | Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use |
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| Secondary | Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) | Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied. | We had 318 participants who have completed the baseline satisfaction survey, and 208 who completed 12 months follow-up survey, due to participants withdrawing from the study and loss to follow-up. | Posted | Mean | Standard Deviation | units (points) on a scale (from 1-5) | Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores |
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| Secondary | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months. | Patients were told to submit an ACT score once a week for 12 months. 311 patients completed at least one ACT score for a total number of 11418 ACT scores submitted using e-AT by all e-AT users (during study period). | Posted | Mean | Standard Deviation | Score (points) ranging from 5-25 | baseline ACT scores were compared to quarters 1, 2, 3, 4. | ACT scores | ACT scores |
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| Secondary | Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study). | The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up. | Posted | Mean | Standard Deviation | Number of days (interrupted or missed) | 1 year |
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| Secondary | Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study. | The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up. | Posted | Mean | Standard Deviation | Number of days (interrupted or missed) | 1 year |
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| Secondary | ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) | ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered. | Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants | Posted | Mean | Standard Deviation | number of ED/hospital admission | 1 year |
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| Secondary | Use of Oral Steroid, Overall | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall. | Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants | Posted | Mean | Standard Deviation | number of oral steroid use | 1 year |
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| Secondary | ED/Hospital Admission, Early vs. Late Patients | ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. | Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between "period" patients were under the e-AT vs "periods" other patients were not using the e-AT. | Posted | Mean | Standard Deviation | number of ED/Hospital admission | 1 year following e-AT use for early and late starting patients |
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| Secondary | Oral Steroid Use, Early vs. Late Patients | Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. | Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between "period" patients were under the e-AT vs "periods" other patients were not using the e-AT. | Posted | Mean | Standard Deviation | number of oral steroid use | 1 year |
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| Secondary | ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) | ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants. | Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between "period" clinics were under the e-AT vs "periods" other clinics were not using the e-AT. | Posted | Number | number of ED/Hospital admission | 3-month period prior to the late clinics starting the e-AT |
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| Secondary | Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants | Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between "period" clinics were under the e-AT vs "periods" other clinics were not using the e-AT. | Posted | Number | number of oral steroid use | 3 month period prior to the late clinics starting the e-AT |
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| Secondary | ED/Hospital Admissions, e-AT vs Usual Care | Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. | Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics. | Posted | Mean | Standard Deviation | Rate per 1000-days | 1 year |
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| Secondary | Oral Steroid Use, e-AT vs Usual Care | Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. | Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics. | Posted | Mean | Standard Deviation | Rate per 1000-days | 1 year |
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| 0 |
| 267 |
| 0 |
| 267 |
| EG001 | Intensive e-AT Intervention | Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users. | 0 | 60 | 0 | 60 |
| EG002 | Usual Care (Non-Randomized Cohort) | Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals. | 0 | 599 | 0 | 599 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| 6 Months |
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| 12 Months |
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| 12 months Follow-up |
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| 6 Months Follow-up |
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| 12 Months Follow-up |
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| 6 Months Follow-Up |
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| 12 Months Follow-up |
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