Asthma
Conditions
Keywords
Adolescents, Mobile based applications, Asthma action plan, Self Efficacy
Brief summary
Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and University of Arkansas for Medical Sciences Center for Distance Health will collaborate to develop a mobile-based Asthma Action Plan application to improve asthma self-management skills specifically targeting adolescents. The investigators hypothesize that an interactive, mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma management guidelines as well as delivering acute management instructions to adolescents with asthma.
Detailed description
A written Asthma Action Plan from a healthcare provider is one of the key features of asthma self-management recommended by the National Asthma Education and Prevention Program asthma guidelines; guidelines-based asthma care has not yet fully translated to the community despite the fact that National Asthma Education and Prevention Program released the first set of national guidelines nearly 2 decades ago. Previous reports have proven that patients with an Asthma Action Plan have better outcomes including fewer acute healthcare utilization visits, fewer days missed from school, and improved symptoms scores compared to patients without an Asthma Action Plan. Recently, mobile-based phone applications and music file (MPEG layer 3)(MP3) players have been utilized in the management of chronic diseases such as asthma and diabetes to provide medication reminders and to provide alternatives to paper dairies for logging symptoms or other health-related data such as peak flow readings or blood glucose readings. We propose to design an application that will fully meet the recommended individualized Asthma Action Plan treatment plan as recommended by national guidelines and will also provide participants with medication reminders, education tips, and data logging/tracking capabilities.
Interventions
OTHERMobile-based Asthma Action Plan
The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly.
Sponsors
University of Arkansas
Arkansas Children's Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. * Mild to severe persistent asthma or poorly controlled asthma. 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: We will assess for mild persistent to severe persistent asthma. Any one of the following, during the prior 4 weeks (as defined by parent interview) 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: We will 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 |
|---|---|---|
| Mobile Asthma Action Plan (AAP) Usage | Eight weeks | Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Utilized the Asthma Action Plan | Eight weeks | The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication. |
| Asthma Self-Efficacy for Adolescent Children | Baseline and eight weeks | 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 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). |
| Asthma Control Test™ Scores | Baseline and eight weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile-based Asthma Action Plan The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Mobile-based Asthma Action Plan |
|---|---|
| Age, Categorical <=18 years | 22 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Mobile Asthma Action Plan (AAP) Usage
Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.
Time frame: Eight weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile-based Asthma Action Plan | Mobile Asthma Action Plan (AAP) Usage | 4.3 days per week |
Secondary
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 eight weeks
Population: All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile-based Asthma Action Plan | Asthma Control Test™ Scores | Eight Weeks, All Participants | 20.3 units on a scale | Standard Deviation 3.94 |
| Mobile-based Asthma Action Plan | Asthma Control Test™ Scores | Baseline All Participants | 19.4 units on a scale | Standard Deviation 4.63 |
| Mobile-based Asthma Action Plan | Asthma Control Test™ Scores | Participants with Uncontrolled Asthma, Baseline | 15.3 units on a scale | Standard Deviation 2.5 |
| Mobile-based Asthma Action Plan | Asthma Control Test™ Scores | Participants with Uncontrolled Asthma, Eight Weeks | 19.1 units on a scale | Standard Deviation 4.2 |
Comparison: This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.p-value: 0.03ANCOVA
Secondary
Asthma Self-Efficacy for Adolescent Children
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 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 eight weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile-based Asthma Action Plan | Asthma Self-Efficacy for Adolescent Children | Eight Weeks (Post-Intervention) | 62.8 units on a scale | Standard Deviation 5.7 |
| Mobile-based Asthma Action Plan | Asthma Self-Efficacy for Adolescent Children | Baseline | 57.2 units on a scale | Standard Deviation 9.1 |
Secondary
Number of Participants That Utilized the Asthma Action Plan
The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.
Time frame: Eight weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile-based Asthma Action Plan | Number of Participants That Utilized the Asthma Action Plan | 11 participants |