Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children

NCT02409277 | Completed Results DMC

• 1 other identifier: 51002874
• Study Type: interventional
• Target: 926
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma

Keywords

Self-Management; Asthma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (17)

• Parent Satisfaction With Care, Standard vs Intensive

  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

  Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups

• Parent Interrupted/Missed Work Days, Standard vs Intensive

  Interrupted/missed work days were measured baseline 3, 6, and 12 months

• Asthma Control Change, Standard vs Intensive

  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

  Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use

Study Arms (3)

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.

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.

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.

Interventions

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.

Intensive e-AT Intervention; Standard e-AT Intervention

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84113, United States

Location

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Flory Nkoy
• Organization: University of Utah

flory.nkoy@hsc.utah.edu

801-662-3660

Study Officials

• Flory Nkoy, MD, MS, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 6, 2015
• Study Start: August 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)