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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: AIM2ACT Behavioral: mHealth Attention Control Condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Block randomization will ensure a 1:1 ratio|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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."
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
|Contact: David A Fedele, Ph.D.||email@example.com|
|United States, Florida|
|UF Health Pediatrics||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Debra McDonald, MA 352-214-9033 firstname.lastname@example.org|
|Contact: Justine Nicholas, MS 352-642-5565 email@example.com|
|Principal Investigator: David A Fedele, PhD|
|Principal Investigator:||David A Fedele, Ph.D.||University of Florida|