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

NCT ID: NCT04448002

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2026-03-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

AIM2ACT

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

mHealth Attention Control Condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sreekala Prabhakaran, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Pediatrics

Gainesville, Florida, United States

Nemours Children's Hospital

Jacksonville, Florida, United States

Countries

United States

References

Fedele DA, Thomas JG, McQuaid EL, Gurka M, Berg CA, Prabhakaran S. AIM2ACT: Randomized controlled trial protocol for a mobile health intervention for early adolescents with asthma. Contemp Clin Trials. 2022 Dec;123:107011. doi: 10.1016/j.cct.2022.107011. Epub 2022 Nov 15.

Reference Type: DERIVED

PMID: 36396068 (View on PubMed)

Other Identifiers

R01HL153119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202000748

Identifier Type: -

Identifier Source: org_study_id