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

NCT02302040 | Completed DMC

• 2 other identifiers: IRB201400921 - N1R21HD083830-01A1
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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

Asthma

Keywords

Adolescent

Outcome Measures

Primary Outcomes (1)

• Family asthma management system scale (FAMSS) will be measured for changes 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 Outcomes (5)

• Spirometry will be used to measure a change in lung function at baseline, 4 months, and 8 months.

  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..

  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.

  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.

  Change in baseline and 4 months

Study Arms (2)

AIM2ACT

EXPERIMENTAL

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

Self-Guided

ACTIVE COMPARATOR

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

Interventions

AIM2ACT BEHAVIORAL

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

AIM2ACT

Self-guided BEHAVIORAL

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

Self-Guided

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• The Miriam Hospital: collaborator
• Rhode Island Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Benton Pediactrics

Gainesville, Florida, 32653, United States

Location

Related Publications (2)

• Fedele DA, Thomas JG, McConville A, McQuaid EL, Voorhees S, Janicke DM, Abu-Hasan M, Chi X, Gurka MJ. Using Mobile Health to Improve Asthma Self-Management in Early Adolescence: A Pilot Randomized Controlled Trial. J Adolesc Health. 2021 Dec;69(6):1032-1040. doi: 10.1016/j.jadohealth.2021.06.011. Epub 2021 Jul 15.

  PMID: 34274211 DERIVED

• Fedele DA, McConville A, Graham Thomas J, McQuaid EL, Janicke DM, Turner EM, Moon J, Abu-Hasan M. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:230-237. doi: 10.1016/j.cct.2017.09.007. Epub 2017 Oct 3.

  PMID: 28986245 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David A Fedele, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2015
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

US (2)