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

NCT02302040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-02-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

AIM2ACT

AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers.

BEHAVIORAL

Self-guided

Paper feedback and collaborative asthma management strategies are provided to early adolescents and caregivers.

Sponsors & Collaborators

  • The Miriam Hospital

    collaborator OTHER
  • Rhode Island Hospital

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of Florida

    lead OTHER

Principal Investigators

  • David A Fedele, Ph.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-02-22
Completion
2019-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302040 on ClinicalTrials.gov