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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile-based Asthma Action Plan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile-based Asthma Action Plan | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara T. Perry, M.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Median | Full Range | days per week | Eight weeks |
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There were zero adverse events that occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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There are no limitations/caveats to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tamara T. Perry | University of Arkansas for Medical Sciences | 501-364-3264 | 43264 | perrytamarat@uams.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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). |
| Baseline and eight weeks |
| 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 eight weeks |
| 1290773 | Background | Forero R, Bauman A, Young L, Larkin P. Asthma prevalence and management in Australian adolescents: results from three community surveys. J Adolesc Health. 1992 Dec;13(8):707-12. doi: 10.1016/1054-139x(92)90068-m. |
| 10894643 | Background | Kyngas HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202. doi: 10.1046/j.1442-2018.1999.00025.x. |
| 9556007 | Background | Braun-Fahrlander C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wuthrich B, Sennhauser FH. Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution. Pediatr Pulmonol. 1998 Mar;25(3):159-66. doi: 10.1002/(sici)1099-0496(199803)25:33.0.co;2-h. |
| 9641931 | Background | Venn A, Lewis S, Cooper M, Hill J, Britton J. Questionnaire study of effect of sex and age on the prevalence of wheeze and asthma in adolescence. BMJ. 1998 Jun 27;316(7149):1945-6. doi: 10.1136/bmj.316.7149.1945. No abstract available. |
| Background | National asthma education and prevention program expert panel report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart Lunch and Blood Institute. 2007:NIH Publication No. 07-4051. |
| 15631966 | Background | Anhoj J, Moldrup C. Feasibility of collecting diary data from asthma patients through mobile phones and SMS (short message service): response rate analysis and focus group evaluation from a pilot study. J Med Internet Res. 2004 Dec 2;6(4):e42. doi: 10.2196/jmir.6.4.e42. |
| 14713908 | Background | Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008. |
| 19005935 | Background | Mosnaim GS, Cohen MS, Rhoads CH, Rittner SS, Powell LH. Use of MP3 players to increase asthma knowledge in inner-city African-American adolescents. Int J Behav Med. 2008;15(4):341-6. doi: 10.1080/10705500802365656. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Number | participants | Eight weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and eight weeks |
|
|
|
| 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). | All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10. | Posted | Mean | Standard Deviation | units on a scale | Baseline and eight weeks |
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| 0 |
| 22 |
| 0 |
| 22 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Participants with Uncontrolled Asthma, Eight Weeks |
|