Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842033
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pediatric Asthma Behavioral: PEAKmAAP Behavioral: PEAKmAAP-DS Behavioral: NutriMap Usual Care Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
PEAKmAAP
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.
 Behavioral: PEAKmAAP
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
PEAKmAAP-Data Sharing (DS)
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.
 Behavioral: PEAKmAAP-DS
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.
Nutrition Map (NutriMap) Usual Care
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.
 Behavioral: NutriMap Usual Care
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Asthma Control Test (ACT) Score [ Time Frame: 12 months ]
    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.

  2. Composite Asthma Severity Index (CASI) score [ Time Frame: 12 months ]
    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.

  3. Healthcare Utilization [ Time Frame: 3 months ]
    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 :
  1. Mediators of Asthma Control [ Time Frame: 12 months ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842033


Contacts
Layout table for location contacts
Contact: Rita C. Hudson Brown, BA 501-364-1538 ext 41538 brownritac@uams.edu
Contact: Jessica H. Turner, BS 501-364-3638 ext 43638 jhturner@uams.edu

Locations
Layout table for location information
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Rita C Hudson Brown, BA    501-364-1538 ext 41538    brownritac@uams.edu   
Contact: Jessica H Turner, BS    501-364-3638 ext 43638    jhturner@uams.edu   
Principal Investigator: Tamara T. Perry, M.D.         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Tamara T. Perry, MD University of Arkansas
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03842033    
Other Study ID Numbers: 206110
1R01NR015988-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arkansas Children's Hospital Research Institute:
Asthma Action Plan
Smartphone App
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases