Trial Outcomes & Findings for A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans (NCT NCT02091869)
NCT ID: NCT02091869
Last Updated: 2018-06-29
Results Overview
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).
COMPLETED
NA
34 participants
Baseline and Six months
2018-06-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Baseline characteristics by cohort
| Measure |
Paper Asthma Action Plan
n=17 Participants
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.
|
Mobile Phone
n=17 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.4 years
n=5 Participants
|
15.3 years
n=7 Participants
|
15.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Six monthsPopulation: 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.
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).
Outcome measures
| Measure |
Paper Asthma Action Plan
n=17 Participants
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.
|
Mobile Phone
n=17 Participants
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.
|
|---|---|---|
|
Change in Asthma Control Test Scores
Six Months, All Participants
|
21 units on a scale
Interval 17.0 to 22.0
|
22 units on a scale
Interval 21.0 to 24.0
|
|
Change in Asthma Control Test Scores
Baseline, All Participants
|
20 units on a scale
Interval 17.0 to 24.0
|
21 units on a scale
Interval 18.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: 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 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).
Outcome measures
| Measure |
Paper Asthma Action Plan
n=17 Participants
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.
|
Mobile Phone
n=17 Participants
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.
|
|---|---|---|
|
Change in Asthma Self-Efficacy Scores
6 Month (Prevention) Post Intervention
|
36 units on a scale
Interval 34.0 to 38.0
|
34 units on a scale
Interval 32.0 to 37.0
|
|
Change in Asthma Self-Efficacy Scores
Baseline (Prevention)
|
35 units on a scale
Interval 33.0 to 38.0
|
35 units on a scale
Interval 34.0 to 37.0
|
|
Change in Asthma Self-Efficacy Scores
6 Month (Management) Post Intervention
|
25 units on a scale
Interval 24.0 to 28.0
|
27 units on a scale
Interval 24.0 to 28.0
|
|
Change in Asthma Self-Efficacy Scores
Baseline (Management))
|
26 units on a scale
Interval 22.0 to 28.0
|
25 units on a scale
Interval 23.0 to 28.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsPopulation: 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.
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.
Outcome measures
| Measure |
Paper Asthma Action Plan
n=17 Participants
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.
|
Mobile Phone
n=14 Participants
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.
|
|---|---|---|
|
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
Mobile Use (Average Days per Week)
|
NA days per week
This was not assessed in the paper asthma action plan group.
|
4.36 days per week
Interval 2.81 to 6.51
|
|
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
Paper Use (Average Days per Week)
|
7.00 days per week
Interval 6.97 to 7.0
|
NA days per week
This was not assessed in the mobile phone group.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsPopulation: Mobile phone usage was not assessed in the paper asthma action plan group.
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.
Outcome measures
| Measure |
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.
|
Mobile Phone
n=17 Participants
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.
|
|---|---|---|
|
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
|
—
|
12.17 times per week
Interval 7.16 to 16.46
|
Adverse Events
Paper Asthma Action Plan
Mobile Phone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tamara T. Perry
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place