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

Pediatric Asthma Clinical Trial

— PEAKmAAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03842033
• Other study ID #: 206110
• Secondary ID: 1R01NR015988-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pediatric Asthma

Intervention

Behavioral:
• PEAKmAAP
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
• 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.
• NutriMap Usual Care
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	3 months
Secondary	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.	12 months