AsthmaAIM2ACTNCT02302040
Applying Interactive Mobile Health to Asthma Care in Teens (AIM2ACT)
A study testing AIM2ACT and Self-guided in people with Asthma, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- AIM2ACT and Self-guided
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to 22 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610
Benton Pediactrics
Gainesville, Florida, 32653
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- AIM2ACT, Self-guided
- Keywords
- Adolescent
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM2ACTBehavioural
AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers.
Self-guidedBehavioural
Paper feedback and collaborative asthma management strategies are provided to early adolescents and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Asthma control test questionnaire will be used to measure a change in symptoms at baseline, 4 months, and 8 months.
Measured: 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..
Asthma-related quality of life questionnaires will be given to measure the overall quality of life changes in baseline, 4 months, and 8 months.
Measured: 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.
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.
Measured: 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.
Family communication during asthma-management tasks will be assessed via the Decision Making Involvement Scale caregiver- and adolescent-reports at baseline and 4 months.
Measured: Change in baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2015
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, Rhode Island Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- David A Fedele, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302040
- Sponsor's protocol ID
- IRB201400921 - N
- Other IDs
- 1R21HD083830-01A1
- Acronym
- AIM2ACT
- Status last verified
- Feb 2021
- First submitted
- 24 Nov 2014
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34274211Fedele 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.
PubMed 28986245
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Approach to Collaborative Asthma Management for Teens & Parents
- ClinicalTrials.gov ID
- NCT02302040
- Acronym / sponsor ID
- AIM2ACT / IRB201400921 - N
- Conditions
- Asthma
- Keywords
- Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- The Miriam Hospital, Rhode Island Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2015
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM2ACT | Experimental | Behavioral: AIM2ACTAIM2ACT 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. |
| Self-Guided | Active comparator | Behavioral: Self-guidedParticipants 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIM2ACTAIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers. | Behavioural | AIM2ACT |
| Self-guidedPaper feedback and collaborative asthma management strategies are provided to early adolescents and caregivers. | Behavioural | Self-Guided |
Primary outcome
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.
5 secondary outcomes
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.
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-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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 34274211Fedele 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.
- Derived from this study: PubMed 28986245Fedele 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.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Fedele, Ph.D. principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIM2ACT and Self-guided in people with Asthma, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302040, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.