Clinical trial NCT03842033: Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Official title: Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Asthma
Keywords: Asthma Action Plan
Smartphone App
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-02-15
Enrollment: 370
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Asthma Control Test (ACT) Score
timeFrame: 3 months
Secondary outcomes:
measure: Mediators of Asthma Control
timeFrame: 12 months
measure: Healthcare Utilization
timeFrame: 12 months
measure: Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes
timeFrame: 12 months
measure: Composite Asthma Severity Index (CASI) score
timeFrame: 12 months
measure: Asthma Control Classification
timeFrame: 12 months
measure: Lung Function and Airway Inflammation
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Tamara T. Perry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacDonald P. Understanding and treating asthma in adolescents. Paediatr Nurs. 2003 Feb;15(1):34-6. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.