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AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma (AIM2ACT)

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ClinicalTrials.gov Identifier: NCT04448002
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
The aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver

Condition or disease Intervention/treatment Phase
Asthma Behavioral: AIM2ACT Behavioral: mHealth Attention Control Condition Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomization will ensure a 1:1 ratio
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: AIM2ACT
AIM2ACT is the experimental arm for the trial. AIM2ACT is a dyadic mHealth intervention designed to sustain caregiver involvement and monitoring as well as guide dyads through collaborative asthma management.
 Behavioral: AIM2ACT
AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers. AIM2ACT contains the following components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of engaging skills training videos to help dyads understand how to use AIM2ACT and work together to set asthma self-management goals, develop and achieve the goals articulated in a behavioral contract, and engage in problem-solving communication.
Active Comparator: mHealth Attention Control Condition
The mHealth attention control condition is the active comparator arm in the trial that accounts for staff attention and novelty of technology based asthma management intervention.
 Behavioral: mHealth Attention Control Condition
Dyads in the mHealth attention control condition will not receive personalized asthma management feedback, will not be guided through collaborative identification and tracking of asthma self-management goals, and will not have access to skills training videos. Instead, dyads will receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self-management.


Outcome Measures
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Primary Outcome Measures :
  1. Asthma Control using asthma control questionnaire [ Time Frame: Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up ]
    Measured via the Asthma Control Test questionnaire which has 5 items that assesses frequency of daytime and nocturnal asthma symptoms, activity limitations, and perceptions of disease control.Adolescents will complete all 5 items independently of caregivers. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma."


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are:

  1. Adolescent is 12-15 years old
  2. Caregiver is between 18-70 years-old
  3. Adolescent lives in the residence of caregiver
  4. Adolescent and caregiver can speak and read English
  5. (a) Adolescent has been diagnosed as having asthma, OR (b) Doctor has stated the adolescent has asthma, OR (c) Adolescent has had breathing problems in the past 12 months
  6. Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks

  7. (a) During the past 14 days (that is, during the past fourteen 24-hour periods that include daytime and nighttime), the adolescent has experienced one or more of the following: (i) Asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on more than 4 separate days; (ii) Woken up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on 1 or more separate nights; (iii) Had to slow down or stop play or usual activities or missed school because of asthma, wheezing, or tightness in the chest, or cough on more than 4 separate days; (iv) Used any asthma rescue medicine (sometimes called a quick relief medicine) on more than 4 separate days

    • OR

      (b) In the past year, adolescent has had one or more of the following: (i) 2 or more exacerbations requiring oral systemic corticosteroids; (ii) 2 or more emergency department visits; (iii) 1 hospitalization; (iv) 2 or more urgent medical care visits due to asthma

    • OR

      (c) Adolescent scores 19 or lower on the Asthma Control Test

Exclusion criteria are -

Families will be excluded if:

  1. The family is currently involved in an asthma management intervention above and beyond usual care, OR
  2. Adolescent is unable to complete study procedures independently.
Contacts and Locations
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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): NCT04448002


Contacts
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Contact: David A Fedele, Ph.D. 352-294-5765 dfedele@phhp.ufl.edu

Locations
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United States, Florida
UF Health Pediatrics Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra McDonald, MA    352-214-9033    debra.mcdonald@peds.ufl.edu   
Contact: Justine Nicholas, MS    352-642-5565    nicholasj@ufl.edu   
Principal Investigator: David A Fedele, PhD         
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: David A Fedele, Ph.D. University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04448002    
Other Study ID Numbers: IRB202000748
R01HL153119 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Adolescent
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases