AsthmaNCT02409277
Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
A study testing Experimental: Standard vs Intensive e-AT Intervention in people with Asthma, run by University of Utah at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Experimental: Standard vs Intensive e-AT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 926 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Facility Eligibility
Clinics are eligible for participation if they meet the following criteria:
- Primary care clinics with the clinical leadership to adopt use of e-AT for asthma management.
- Have patients between 2 and 17 years of age with persistent asthma.
- Ability of the facility to accommodate patient enrollment and training about use of e-AT.
Patient Inclusion Criteria
- Children ages 2 through 17 years and their parents (main parents or caregiver)
- English speakers
- Children who received or are receiving asthma treatment (at participating clinics).
- Parents have Internet access
- Children with persistent asthma.
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Asthma
- Being tested
- Experimental: Standard vs Intensive e-AT Intervention
- Keywords
- Self-Management, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Standard vs Intensive e-AT InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experimental: Standard vs Intensive e-AT Intervention |
| 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. Receives: Other: Experimental: Standard vs Intensive e-AT Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL
Secondary outcomes (17)
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".
Measured: Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startAug 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 926 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Flory Nkoy, University of Utah
- Investigators
- Flory Nkoy, MD, MS, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409277
- Sponsor's protocol ID
- 51002874
- Status last verified
- Jan 2020
- First submitted
- 25 Mar 2015
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We can only share completely de-identified data. Request can be sent to my email: flory.nkoy@hsc.utah.edu
Publications
CDC. National Health Interview Survey (NHIS) Data2009. http://www.cdc.gov/asthma/nhis/09/data.htm
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.
PubMed 21355352CDC. Healthy Youth! Health Topics, Asthma2009.
Wessel L, Spain J. The Chronic Care Model: A Collaborative Approach to Preventing and Treating Asthma in Infants and Young Children. January 2005. EJ847179
Association AL. Asthma & Children Fact Sheet 2012. http://www.lung.org/lung-disease/asthma/resources/facts-and-figures/asthma-children-fact-sheet.html
Farber HJ. Risk of readmission to hospital for pediatric asthma. J Asthma. 1998;35(1):95-9. doi: 10.3109/02770909809055410.
PubMed 9513588Minkovitz CS, Andrews JS, Serwint JR. Rehospitalization of children with asthma. Arch Pediatr Adolesc Med. 1999 Jul;153(7):727-30. doi: 10.1001/archpedi.153.7.727.
PubMed 10401806Lieu TA, Quesenberry CP, Sorel ME, Mendoza GR, Leong AB. Computer-based models to identify high-risk children with asthma. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1173-80. doi: 10.1164/ajrccm.157.4.9708124.
PubMed 9563736Rea HH, Scragg R, Jackson R, Beaglehole R, Fenwick J, Sutherland DC. A case-control study of deaths from asthma. Thorax. 1986 Nov;41(11):833-9. doi: 10.1136/thx.41.11.833.
PubMed 3824270Weiss KB, Gergen PJ, Hodgson TA. An economic evaluation of asthma in the United States. N Engl J Med. 1992 Mar 26;326(13):862-6. doi: 10.1056/NEJM199203263261304.
PubMed 1542323Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
PubMed 9309994Bloomberg GR, Trinkaus KM, Fisher EB Jr, Musick JR, Strunk RC. Hospital readmissions for childhood asthma: a 10-year metropolitan study. Am J Respir Crit Care Med. 2003 Apr 15;167(8):1068-76. doi: 10.1164/rccm.2201015.
PubMed 12684246Crane J, Pearce N, Burgess C, Woodman K, Robson B, Beasley R. Markers of risk of asthma death or readmission in the 12 months following a hospital admission for asthma. Int J Epidemiol. 1992 Aug;21(4):737-44. doi: 10.1093/ije/21.4.737.
PubMed 1521979Li D, German D, Lulla S, Thomas RG, Wilson SR. Prospective study of hospitalization for asthma. A preliminary risk factor model. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):647-55. doi: 10.1164/ajrccm.151.3.7881651.
PubMed 7881651To T, Dick P, Feldman W, Hernandez R. A cohort study on childhood asthma admissions and readmissions. Pediatrics. 1996 Aug;98(2 Pt 1):191-5.
PubMed 8692616
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
- ClinicalTrials.gov ID
- NCT02409277
- Acronym / sponsor ID
- 51002874
- Conditions
- Asthma
- Keywords
- Self-Management, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 926 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Aug 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard e-AT Intervention | Experimental | Other: Experimental: Standard vs Intensive e-AT InterventionPatients 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. |
| Intensive e-AT Intervention | Experimental | Other: Experimental: Standard vs Intensive e-AT InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Standard vs Intensive e-AT InterventionPatients 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. | Other | Intensive e-AT Intervention, Standard e-AT Intervention |
Primary outcome
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
Time frame: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after 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 QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention)
Time frame: Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL
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.
17 secondary outcomes
Parent Satisfaction With Care, Standard vs Intensive
Time frame: Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions
Child Interrupted/Missed School Days, Standard vs Intensive
Time frame: Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups
Parent Interrupted/Missed Work Days, Standard vs Intensive
Time frame: Interrupted/missed work days were measured baseline 3, 6, and 12 months
Asthma Control Change, Standard vs Intensive
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: baseline ACT scores were compared to quarters 1, 2, 3, 4.
Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime)
Time frame: 1 year
Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime)
Time frame: 1 year
ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention)
Time frame: 1 year
Use of Oral Steroid, Overall
Time frame: 1 year
ED/Hospital Admission, Early vs. Late Patients
Time frame: 1 year following e-AT use for early and late starting patients
Oral Steroid Use, Early vs. Late Patients
Time frame: 1 year
ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT)
Time frame: 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)
Time frame: 3 month period prior to the late clinics starting the e-AT
ED/Hospital Admissions, e-AT vs Usual Care
Time frame: 1 year
Oral Steroid Use, e-AT vs Usual Care
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCDC. National Health Interview Survey (NHIS) Data2009. http://www.cdc.gov/asthma/nhis/09/data.htm
- Background: PubMed 21355352Akinbami 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.
- BackgroundCDC. Healthy Youth! Health Topics, Asthma2009.
- BackgroundWessel L, Spain J. The Chronic Care Model: A Collaborative Approach to Preventing and Treating Asthma in Infants and Young Children. January 2005. EJ847179
- BackgroundAssociation AL. Asthma & Children Fact Sheet 2012. http://www.lung.org/lung-disease/asthma/resources/facts-and-figures/asthma-children-fact-sheet.html
- Background: PubMed 9513588Farber HJ. Risk of readmission to hospital for pediatric asthma. J Asthma. 1998;35(1):95-9. doi: 10.3109/02770909809055410.
- Background: PubMed 10401806Minkovitz CS, Andrews JS, Serwint JR. Rehospitalization of children with asthma. Arch Pediatr Adolesc Med. 1999 Jul;153(7):727-30. doi: 10.1001/archpedi.153.7.727.
- Background: PubMed 9563736Lieu TA, Quesenberry CP, Sorel ME, Mendoza GR, Leong AB. Computer-based models to identify high-risk children with asthma. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1173-80. doi: 10.1164/ajrccm.157.4.9708124.
- Background: PubMed 3824270Rea HH, Scragg R, Jackson R, Beaglehole R, Fenwick J, Sutherland DC. A case-control study of deaths from asthma. Thorax. 1986 Nov;41(11):833-9. doi: 10.1136/thx.41.11.833.
- Background: PubMed 1542323Weiss KB, Gergen PJ, Hodgson TA. An economic evaluation of asthma in the United States. N Engl J Med. 1992 Mar 26;326(13):862-6. doi: 10.1056/NEJM199203263261304.
- Background: PubMed 9309994Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
- Background: PubMed 12684246Bloomberg GR, Trinkaus KM, Fisher EB Jr, Musick JR, Strunk RC. Hospital readmissions for childhood asthma: a 10-year metropolitan study. Am J Respir Crit Care Med. 2003 Apr 15;167(8):1068-76. doi: 10.1164/rccm.2201015.
- Individual participant dataSharing planned: No. We can only share completely de-identified data. Request can be sent to my email: flory.nkoy@hsc.utah.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flory Nkoy, MD, MS, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Standard vs Intensive e-AT Intervention in people with Asthma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409277, which also lists 69 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.