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Mobile Health Tool for Asthma (AIM2ACT Trial)

N/A
Recruiting
Led By David A Fedele, Ph.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 has had an active inhaled corticosteroid prescription for ≥ 4 weeks
Caregiver is between 18-70 years-old
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

AIM2ACT Trial 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.Check my eligibility
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.See study design
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.

AIM2ACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been using an inhaled corticosteroid for at least 4 weeks.
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My caregiver is between 18 and 70 years old.
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I have had frequent asthma symptoms or needed emergency care for asthma recently.
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I have asthma or have had breathing issues in the last year.
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I am between 12 and 15 years old.

AIM2ACT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma Control using asthma control questionnaire

AIM2ACT 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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
714,996 Total Patients Enrolled
15 Trials studying Asthma
1,272 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,437 Total Patients Enrolled
276 Trials studying Asthma
112,326 Patients Enrolled for Asthma
David A Fedele, Ph.D.Principal InvestigatorUniversity of Florida
2 Previous Clinical Trials
136 Total Patients Enrolled
1 Trials studying Asthma
92 Patients Enrolled for Asthma

Media Library

AIM2ACT Clinical Trial Eligibility Overview. Trial Name: NCT04448002 — N/A
Asthma Clinical Trial 2023: AIM2ACT Highlights & Side Effects. Trial Name: NCT04448002 — N/A
AIM2ACT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448002 — N/A
Asthma Research Study Groups: AIM2ACT, mHealth Attention Control Condition

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor welcome elderly participants?

"To participate in this trial, patients should be between 12 and 70. For those under 18 or over 65 years old, there are 119 and 199 studies respectively that they may take part in."

Answered by AI

What is the uppermost threshold of participants in this study?

"Affirmative, the data on clinicaltrials.gov reveals that recruitment is currently ongoing for this research trial which was posted on April 23rd 2021. The last update occurred on June 28th 2022 and there are 320 participants required from a single site."

Answered by AI

What qualities make individuals suitable candidates for this experiment?

"This medical research is recruiting 320 people with asthma aged 12 and 70. Qualifying criteria include: a minor living in the care of an adult between 18-70, evidence of past or present asthmatic symptoms (e.g wheezing, chest tightness) over 4 days/nights within 2 weeks, use of rescue medication >4x during last year OR one or more exacerbations requiring oral systemic corticosteroids; ED visits; hospitalizations; urgent medical care related to asthma AND Asthma Control Test score <19."

Answered by AI

Are new participants being recruited for this clinical experiment?

"Indeed, the information on clinicaltrials.gov declares that this experiment is currently recruiting patients. It was initially published on April 23rd 2021 and recently updated June 28th 2022; 320 participants are required for 1 site to be involved in the trial."

Answered by AI
~65 spots leftby Jan 2025