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Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients (PEAKmAAP)

Primary Purpose

Pediatric Asthma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEAKmAAP
PEAKmAAP-DS
NutriMap Usual Care
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Asthma focused on measuring Asthma Action Plan, Smartphone App

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥12 and <21 years
  • Persistent asthma according to national guidelines criteria
  • Asthma Control Test (ACT) score ≤19
  • Prescribed a preventive (controller) asthma medication in the past 6 months
  • Access to a smartphone compatible with the PEAKmAAP and NutriMap
  • Access to the internet
  • Able to read and speak English

Exclusion Criteria:

  • Significant underlying respiratory disease other than asthma, such as cystic fibrosis
  • Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
  • Current smoker
  • Participation in the investigator's or other asthma clinical trials in the previous 6 months

Sites / Locations

  • Arkansas Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

PEAKmAAP

PEAKmAAP-Data Sharing (DS)

Nutrition Map (NutriMap) Usual Care

Arm Description

The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.

PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.

Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.

Outcomes

Primary Outcome Measures

Change in Asthma Control Test (ACT) Score
ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including (ACT) score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function.
Composite Asthma Severity Index (CASI) score
The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations.
Healthcare Utilization
We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning.

Secondary Outcome Measures

Mediators of Asthma Control
Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL) to determine asthma self-efficacy. We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines.

Full Information

First Posted
May 15, 2017
Last Updated
July 18, 2023
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03842033
Brief Title
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Acronym
PEAKmAAP
Official Title
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
Detailed Description
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH). We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Asthma
Keywords
Asthma Action Plan, Smartphone App

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will conduct a randomized, controlled trial of 372 adolescents with uncontrolled mild-severe persistent asthma to examine the effectiveness of a personalized, interactive PEAKmAAP application with and without PCP data sharing in reducing asthma morbidity. The trial includes 3 groups: 1) a group utilizing the PEAKmAAP alone, 2) a group utilizing the PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a usual care NutriMapgroup utilizing an application with daily non-asthma related reminders for attention control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEAKmAAP
Arm Type
Other
Arm Description
The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.
Arm Title
PEAKmAAP-Data Sharing (DS)
Arm Type
Other
Arm Description
PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.
Arm Title
Nutrition Map (NutriMap) Usual Care
Arm Type
Other
Arm Description
Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.
Intervention Type
Behavioral
Intervention Name(s)
PEAKmAAP
Intervention Description
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
Intervention Type
Behavioral
Intervention Name(s)
PEAKmAAP-DS
Intervention Description
This group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time.
Intervention Type
Behavioral
Intervention Name(s)
NutriMap Usual Care
Intervention Description
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.
Primary Outcome Measure Information:
Title
Change in Asthma Control Test (ACT) Score
Description
ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including (ACT) score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function.
Time Frame
12 months
Title
Composite Asthma Severity Index (CASI) score
Description
The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations.
Time Frame
12 months
Title
Healthcare Utilization
Description
We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mediators of Asthma Control
Description
Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL) to determine asthma self-efficacy. We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥12 and <21 years Persistent asthma according to national guidelines criteria Asthma Control Test (ACT) score ≤19 Prescribed a preventive (controller) asthma medication in the past 6 months Access to a smartphone compatible with the PEAKmAAP and NutriMap Access to the internet Able to read and speak English Exclusion Criteria: Significant underlying respiratory disease other than asthma, such as cystic fibrosis Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma Current smoker Participation in the investigator's or other asthma clinical trials in the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara T. Perry, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

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