A Randomized Trial Examining the Effectiveness of Mobile-... | NCT02091869

NCT02091869

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University of Arkansas	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paper Asthma Action Plan	Experimental	Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.	Other: Paper Asthma Action Plan
Mobile Phone	Experimental	Participants will record asthma symptoms, medication usage, and peak flow data on their phones.	Device: Mobile Phone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paper Asthma Action Plan	Other	Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.	Paper Asthma Action Plan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Baseline and Six months

Secondary Outcomes

Measure	Description	Time Frame
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).

Other Outcomes

Measure	Description	Time Frame
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.	Six months

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Tamara T Perry, MD,FAAP	University of Arkansas	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital Research Institute		Little Rock	Arkansas	72202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17947969	Background	Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.
19221156	Background	Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
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).	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.	Posted		Median	Full Range	units on a scale		Baseline and Six months

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Title	Organization	Phone	Extension	Email
Dr. Tamara T. Perry	University of Arkansas for Medical Sciences	501-364-1538	41538	perrytamarat@uams.edu

ID	Term
D001249	Asthma

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Title	Description
OG000	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.
OG001	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.