Applying Interactive Mobile Health to Asthma Care in Teens (AIM2ACT) (AIM2ACT)

February 17, 2021 updated by: University of Florida

mHealth Approach to Collaborative Asthma Management for Teens & Parents

The aims of this application are to develop and test AIM2ACT, a mobile health (mHealth) tool, delivered via smartphones, that fosters helpful caregiver support as early adolescents (ages 12-15) with persistent asthma develop and master asthma self-management behaviors. To facilitate helpful caregiver support, AIM2ACT uses mHealth technology to determine tailored intervention targets for each family. AIM2ACT then helps caregiver/adolescent dyads set asthma management goals by automatically guiding families through a structured process that includes the supportive behavioral management strategies of goal setting, contingency management, and problem solving communication. Skills-training videos for adolescents and caregivers provide guidance on how to complete each collaborative asthma management component.

AIM2ACT will be developed through feedback from an advisory board of adolescent-caregiver dyads from the target user population and a pediatric pulmonologist. Following advisory board feedback, the investigators will conduct a pilot randomized controlled trial of AIM2ACT with 50 early adolescents with poorly controlled asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive AIM2ACT or a self-guided condition for a 4 month intervention period. Participants in the self-guided condition will be given general information on supportive behavioral management techniques they can use to target improvement in asthma self-management behaviors. Outcomes include whether participants prefer AIM2ACT or the self-guided condition. Additionally, AIM2ACT and the self-guided condition will be compared to see if there are differences in changes in family asthma management (primary outcome), lung function, asthma control, asthma-related quality of life, and self-efficacy for asthma management. Data will be collected before participants are assigned to AIM2ACT or the self-guided control, post-treatment, and 4 month follow-up time points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As a participant in the study the following will take place:

Questionnaires will be filled out which will include medical history, including asthma symptoms and control, and questions related to quality of life. In addition, an interview will be completed which assesses the participants asthma management.

During this visit a brief training on how to complete lung function testing with a portable device will be demonstrated. The participant will breathe into twice per day for 14 days and then the device will be collected at the end of the 14 day period.

Randomization A computer will randomly chose one of the two programs; Program A or Program B. Random assignment is like rolling a dice to decide which group a person is assigned to. Both Program A and B are 4 months in length.

Program A the participant will answer questions about asthma management for a one-week period on a smartphone program. A smartphone can be provided for the duration of the study. After the one-week period, a report will be received on the smartphone about areas of asthma management that are going well and areas that may be in need of improvement. Next, brief meetings with study personnel to help determine things that will help improve asthma management. This information will be entered into a smartphone program. The participant will continue to use the smartphone program for a four month period.

Program B the participant answer questions about asthma for a one-week period on a paper and pencil diary. The participant will receive a paper copy of feedback from study personnel related to areas of asthma management that are going well and areas that may be in need of improvement. The participant will then be given information on techniques they can use to target identified areas for improvement. The participant will be encouraged to use these strategies to for a 4 month period.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32653
        • Benton Pediactrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lives in residence of caregiver,
  • adolescent meets screening criteria for current persistent asthma,
  • adolescent has uncontrolled asthma as indicated by a score of ≤ 19 on the Asthma Control Test,
  • poorly controlled asthma according to National Heart, Lung, and Blood Institute (NHLBI) guidelines
  • adolescent-caregiver dyad speak and read English

Exclusion Criteria:

  • family is currently involved in an asthma management intervention, or
  • adolescent has well controlled asthma as indicated by a score of ≥ 20 on the Asthma Control Test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIM2ACT
AIM2ACT uses existing mHealth technology developed by the study team to elucidate tailored intervention targets for each family. AIM2ACT then facilitates collaborative caregiver/adolescent asthma management by automatically guiding dyads through a structured process that includes the supportive behavioral management strategies of goal setting, contingency management, and problem solving communication. Skills-training videos for adolescents and caregivers provide guidance on how to complete each collaborative asthma management component.
Behavioral: AIM2ACT
AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers.
Active Comparator: Self-Guided
Participants in the self-guided control condition will be given general information on supportive behavioral management techniques they can use to target improvement in asthma self-management behaviors. The control condition will serve as an attention control and is designed to optimize recruitment and sustain interest while concurrently having a minimal impact on asthma management.
Behavioral: Self-guided
Paper feedback and collaborative asthma management strategies are provided to early adolescents and caregivers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family asthma management system scale (FAMSS) will be measured for changes in baseline, 4 months, and 8 months.
Time Frame: Change in baseline, 4 months, and 8 months.
Family Asthma Management System Scale (FAMSS) a validated family clinical interview that assesses core aspects of asthma management including medication adherence, symptom assessment and response, and integration of asthma into the family system.
Change in baseline, 4 months, and 8 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry will be used to measure a change in lung function at baseline, 4 months, and 8 months.
Time Frame: Change in baseline, 4 months, and 8 months.
Lung function will be measured with spirometry at baseline, 4 months, and 8 months between the two groups to determine if the use of the AIM2ACT mHealth platform improved symptoms.
Change in baseline, 4 months, and 8 months.
Asthma control test questionnaire will be used to measure a change in symptoms at baseline, 4 months, and 8 months.
Time Frame: Change in baseline, 4 months, and 8 months.
Asthma control test questionnaire will be used to measure a change in symptoms at baseline, 4 months, and 8 months.
Change in baseline, 4 months, and 8 months.
Asthma-related quality of life questionnaires will be given to measure the overall quality of life changes in baseline, 4 months, and 8 months..
Time Frame: Change in baseline, 4 months, and 8 months.
Asthma-related quality of life questionnaires will be given to measure the overall quality of life changes in baseline, 4 months, and 8 months.
Change in baseline, 4 months, and 8 months.
Self-efficacy for asthma management questionnaire will be given to measure the overall improvement of the quality of life change in baseline, 4 months, and 8 months.
Time Frame: Change in baseline, 4 months, and 8 months.
Asthma management efficacy questionnaire will be given to measure the overall improvement of the quality of life change in baseline, 4 months, and 8 months.
Change in baseline, 4 months, and 8 months.
Family communication during asthma-management tasks will be assessed via the Decision Making Involvement Scale caregiver- and adolescent-reports at baseline and 4 months.
Time Frame: Change in baseline and 4 months
Family communication during asthma-management tasks will be assessed via the Decision Making Involvement Scale caregiver- and adolescent-reports at baseline and 4 months.
Change in baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Miriam Hospital
Rhode Island Hospital

Investigators

  • Principal Investigator: David A Fedele, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

February 22, 2019

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400921 - N
  • 1R21HD083830-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on AIM2ACT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe