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

Primary Purpose

Asthma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AIM2ACT

mHealth Attention Control Condition

About this trial

This is an interventional treatment trial for Asthma focused on measuring Adolescent

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria are:

Adolescent is 12-15 years old
Caregiver is between 18-70 years-old
Adolescent lives in the residence of caregiver
Adolescent and caregiver can speak and read English
(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
Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks
(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:

The family is currently involved in an asthma management intervention above and beyond usual care, OR
Adolescent is unable to complete study procedures independently.

Sites / Locations

UF Health PediatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AIM2ACT

mHealth Attention Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Asthma Control using asthma control questionnaire

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."

Secondary Outcome Measures

Full Information

NCT ID

NCT04448002

First Posted

June 22, 2020

Last Updated

September 15, 2023

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04448002

Brief Title

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

Acronym

AIM2ACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 23, 2021 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Adolescent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Block randomization will ensure a 1:1 ratio

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AIM2ACT

Arm Type

Experimental

Arm Description

Arm Title

mHealth Attention Control Condition

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

AIM2ACT

Intervention Description

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

Intervention Name(s)

mHealth Attention Control Condition

Intervention Description

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.

Primary Outcome Measure Information:

Title

Asthma Control using asthma control questionnaire

Description

Time Frame

Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria are: Adolescent is 12-15 years old Caregiver is between 18-70 years-old Adolescent lives in the residence of caregiver Adolescent and caregiver can speak and read English (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 Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks (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: The family is currently involved in an asthma management intervention above and beyond usual care, OR Adolescent is unable to complete study procedures independently.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David A Fedele, Ph.D.

Phone

352-294-5765

dfedele@phhp.ufl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mona Sayedul Huq, PhD

Phone

352-294-8557

monahuq@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Fedele, Ph.D.

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

UF Health Pediatrics

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily Jackson

Phone

352-294-8959

ejackson1@ufl.edu

First Name & Middle Initial & Last Name & Degree

Mona Sayedul Huq, PhD

Phone

305-294-8557

monahuq@ufl.edu

First Name & Middle Initial & Last Name & Degree

David A Fedele, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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