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

Not Applicable

Active, not recruiting

• Conditions: Asthma
• Interventions: Behavioral: AIM2ACT; Behavioral: mHealth Attention Control Condition

• Registration Number: NCT04448002
• Lead Sponsor: University of Florida

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Study Start: 2021-04-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIM2ACT	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.
mHealth Attention Control Condition	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.

Primary Outcome Measures

Name	Time	Method
Asthma Control using asthma control questionnaire	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."

Trial Locations

Locations (2)

UF Health Pediatrics; 🇺🇸 Gainesville, Florida, United States

Nemours Children's Hospital; 🇺🇸 Jacksonville, Florida, United States