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

NCT03842033 | Active Not Recruiting DMC

• 2 other identifiers: 2061101R01NR015988-01A1
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Asthma

Keywords

Asthma Action Plan; Smartphone App

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Test (ACT) Score

  The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT \>19 (controlled asthma) at 3 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.

  3 months

Secondary Outcomes (6)

• Mediators of Asthma Control

  12 months

• Healthcare Utilization

  12 months

• Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes

  12 months

• Composite Asthma Severity Index (CASI) score

  12 months

• Asthma Control Classification

  12 months

Study Arms (3)

PEAKmAAP

OTHER

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

PEAKmAAP-Data Sharing (DS)

OTHER

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

Nutrition Map (NutriMap) Usual Care

OTHER

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

Interventions

PEAKmAAP BEHAVIORAL

The PEAKmAAP group will use a mobile "app" that will help manage asthma.

PEAKmAAP

PEAKmAAP-DS BEHAVIORAL

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.

PEAKmAAP-Data Sharing (DS)

NutriMap Usual Care BEHAVIORAL

This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.

Nutrition Map (NutriMap) Usual Care

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (12)

• MacDonald P. Understanding and treating asthma in adolescents. Paediatr Nurs. 2003 Feb;15(1):34-6. No abstract available.

  PMID: 12655953 BACKGROUND

• Naimi DR, Freedman TG, Ginsburg KR, Bogen D, Rand CS, Apter AJ. Adolescents and asthma: why bother with our meds? J Allergy Clin Immunol. 2009 Jun;123(6):1335-41. doi: 10.1016/j.jaci.2009.02.022. Epub 2009 Apr 22.

  PMID: 19395075 BACKGROUND

• Braun-Fahrlander C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wuthrich B, Sennhauser FH. Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution. Pediatr Pulmonol. 1998 Mar;25(3):159-66. doi: 10.1002/(sici)1099-0496(199803)25:33.0.co;2-h.

  PMID: 9556007 BACKGROUND

• Venn A, Lewis S, Cooper M, Hill J, Britton J. Questionnaire study of effect of sex and age on the prevalence of wheeze and asthma in adolescence. BMJ. 1998 Jun 27;316(7149):1945-6. doi: 10.1136/bmj.316.7149.1945. No abstract available.

  PMID: 9641931 BACKGROUND

• Forero R, Bauman A, Young L, Larkin P. Asthma prevalence and management in Australian adolescents: results from three community surveys. J Adolesc Health. 1992 Dec;13(8):707-12. doi: 10.1016/1054-139x(92)90068-m.

  PMID: 1290773 BACKGROUND

• Kyngas HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202. doi: 10.1046/j.1442-2018.1999.00025.x.

  PMID: 10894643 BACKGROUND

• Raherison C, Tunon-de-Lara JM, Vernejoux JM, Taytard A. Practical evaluation of asthma exacerbation self-management in children and adolescents. Respir Med. 2000 Nov;94(11):1047-52. doi: 10.1053/rmed.2000.0888.

  PMID: 11127490 BACKGROUND

• Buston KM, Wood SF. Non-compliance amongst adolescents with asthma: listening to what they tell us about self-management. Fam Pract. 2000 Apr;17(2):134-8. doi: 10.1093/fampra/17.2.134.

  PMID: 10758075 BACKGROUND

• Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7.

  PMID: 24494626 BACKGROUND

• McQuaid EL, Kopel SJ, Klein RB, Fritz GK. Medication adherence in pediatric asthma: reasoning, responsibility, and behavior. J Pediatr Psychol. 2003 Jul-Aug;28(5):323-33. doi: 10.1093/jpepsy/jsg022.

  PMID: 12808009 BACKGROUND

• Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.

  PMID: 17947969 BACKGROUND

• Perry TT, Turner JH, Berlinski A, Simmons LA, Brown RH, Neal K, Marshall SA, He X, Chung S, Brown A, Spencer Rd HJ, Bian J. Comparing a Guideline-Based Mobile Health Intervention Versus Usual Care for High-Risk Adolescents With Asthma: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 25;14:e69903. doi: 10.2196/69903.

  PMID: 40712131 DERIVED

Study Officials

• Tamara T. Perry, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: February 15, 2019
• Study Start: March 4, 2019
• Primary Completion: June 1, 2024
• Study Completion: December 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)