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

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ClinicalTrials.gov Identifier: NCT02302040
Recruitment Status : Recruiting
First Posted : November 26, 2014
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
The Miriam Hospital
Rhode Island Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: AIM2ACT Behavioral: Self-guided Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: mHealth Approach to Collaborative Asthma Management for Teens & Parents
Study Start Date : December 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302040


Contacts
Contact: David A Fedele, Ph.D. 352-294-5765 dfedele@phhp.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: David Fedele, Ph.D.    352-294-5765    dfedele@phhp.ufl.edu   
Benton Pediactrics Recruiting
Gainesville, Florida, United States, 32653
Sponsors and Collaborators
University of Florida
The Miriam Hospital
Rhode Island Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: David A Fedele, Ph.D. University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02302040     History of Changes
Other Study ID Numbers: IRB201400921 - N
1R21HD083830-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Adolescent

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases