Asthma
Conditions
Keywords
Adolescents, Asthma, Asthma Symptoms
Brief summary
The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.
Detailed description
The investigators propose to conduct a randomized trial to examine the effectiveness of a mobile-based Asthma Action Plan that will meet the national guidelines recommendation for individualized Asthma Action Plan treatment plans. The mobile app will provide immediate instructions and feedback once data is entered by the participants. This is an randomized trial which will be compared with an paper asthma action plan. Participants will be randomized through a statistical table. The mobile app will be password and Health Information Portability and Protection Act protected.
Interventions
DEVICEMobile Phone
Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.
OTHERPaper Asthma Action Plan
Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.
Sponsors
University of Arkansas
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 12 and ≤ 17 years. * Access to Apple or Android based smart phone * Mild to severe persistent asthma or poorly controlled asthma (see definitions below). o A different assessment of eligibility will be performed depending on whether or not the parent reports use of a preventive asthma medication at baseline. This is consistent with 2007 National Asthma Education Prevention Program recommendations that make a strong distinction between classifying asthma severity (for children not using preventive medications) and assessing control (for children using preventive medications). If a child has used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will assess severity.) * Children not using a preventive medication at baseline: Assess for mild persistent to severe persistent asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine severity: * An average of \>2 days per week with asthma symptoms * \>2 days per week with rescue medication use * ≥2 nights per month awakened with nighttime symptoms * Minor limitation of activity * ≥2 episodes of asthma during the past year that have required systemic corticosteroids * Children using a preventive medication at baseline: Assess for poorly controlled asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine control: * An average of \>2 days per week with asthma symptoms * \>2 days per week with rescue medication use * ≥2 nights per month awakened with nighttime symptoms * Some limitation of activity * ≥2 episodes of asthma during the past year that have required systemic corticosteroids.
Exclusion criteria
* Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures. * Significant co-morbid conditions (such as moderate to severe developmental delay, i.e. special education classroom or diagnosis) that could preclude participation in an education-based intervention. * Inability to speak or understand English (child or parent). * Children in foster care or other situations in which consent cannot be obtained from a guardian. * Prior enrollment in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test Scores | Baseline and Six months | The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Self-Efficacy Scores | Baseline and Six months | The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from not at all sure (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to completely sure (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | Six months | We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paper Asthma Action Plan Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage. | 17 |
| Mobile Phone Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app. | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Mobile Phone | Paper Asthma Action Plan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.3 years | 15.4 years | 15.4 years |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Change in Asthma Control Test Scores
The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5).
Time frame: Baseline and Six months
Population: Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. The biostatistician was not be involved in testing or intervention procedures.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paper Asthma Action Plan | Change in Asthma Control Test Scores | Six Months, All Participants | 21 units on a scale |
| Paper Asthma Action Plan | Change in Asthma Control Test Scores | Baseline, All Participants | 20 units on a scale |
| Mobile Phone | Change in Asthma Control Test Scores | Six Months, All Participants | 22 units on a scale |
| Mobile Phone | Change in Asthma Control Test Scores | Baseline, All Participants | 21 units on a scale |
Secondary
Change in Asthma Self-Efficacy Scores
The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from not at all sure (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to completely sure (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention).
Time frame: Baseline and Six months
Population: Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paper Asthma Action Plan | Change in Asthma Self-Efficacy Scores | 6 Month (Prevention) Post Intervention | 36 units on a scale |
| Paper Asthma Action Plan | Change in Asthma Self-Efficacy Scores | Baseline (Prevention) | 35 units on a scale |
| Paper Asthma Action Plan | Change in Asthma Self-Efficacy Scores | 6 Month (Management) Post Intervention | 25 units on a scale |
| Paper Asthma Action Plan | Change in Asthma Self-Efficacy Scores | Baseline (Management)) | 26 units on a scale |
| Mobile Phone | Change in Asthma Self-Efficacy Scores | Baseline (Management)) | 25 units on a scale |
| Mobile Phone | Change in Asthma Self-Efficacy Scores | 6 Month (Prevention) Post Intervention | 34 units on a scale |
| Mobile Phone | Change in Asthma Self-Efficacy Scores | 6 Month (Management) Post Intervention | 27 units on a scale |
| Mobile Phone | Change in Asthma Self-Efficacy Scores | Baseline (Prevention) | 35 units on a scale |
Other Pre-specified
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.
Time frame: Six months
Population: Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. Three participants did not use the mobile app per protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paper Asthma Action Plan | Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | Mobile Use (Average Days per Week) | NA days per week |
| Paper Asthma Action Plan | Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | Paper Use (Average Days per Week) | 7.00 days per week |
| Mobile Phone | Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | Mobile Use (Average Days per Week) | 4.36 days per week |
| Mobile Phone | Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | Paper Use (Average Days per Week) | NA days per week |
Other Pre-specified
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.
Time frame: Six months
Population: Mobile phone usage was not assessed in the paper asthma action plan group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Phone | Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans | 12.17 times per week |