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Mobile Health Tool for Asthma (AIM2ACT Trial)

N/A

Waitlist Available

Led By Sreekala Prabhakaran, M.D.

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescent is 12-15 years old

Must not have

Adolescent is unable to complete study procedures independently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for asthma in adolescents and will compare it to the current standard of care.

Who is the study for?

This trial is for early adolescents aged 12-15 with poorly controlled asthma and their caregivers (18-70 years old). Participants must speak English, live with the caregiver, and have experienced recent frequent asthma symptoms or have a history of severe asthma events. Adolescents should be on inhaled corticosteroids and diagnosed with asthma.

What is being tested?

The AIM2ACT study tests a mobile health tool designed to help young teens manage their asthma against an attention control condition. It's a randomized controlled trial involving 160 pairs of adolescents and caregivers to see if the tool can improve long-term asthma control.

What are the potential side effects?

Since this trial involves a mobile health tool rather than medication, traditional side effects are not expected. However, there may be indirect effects related to changes in behavior or stress levels due to increased self-management responsibilities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 15 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot do the study tasks by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma Control using asthma control questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AIM2ACTExperimental Treatment1 Intervention

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 II: mHealth Attention Control ConditionActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AIM2ACT

2015

N/A

~100

0 / 2Eligibility criteria met