Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-20 @ 11:06 AM
Study NCT ID:
NCT02091869
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'perrytamarat@uams.edu', 'phone': '501-364-1538', 'title': 'Dr. Tamara T. Perry', 'phoneExt': '41538', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were not limitations and caveats.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Asthma Control Test Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'OG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}], 'classes': [{'title': 'Six Months, All Participants', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '22'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '24'}]}]}, {'title': 'Baseline, All Participants', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '24'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Six months', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Self-Efficacy Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'OG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}], 'classes': [{'title': '6 Month (Prevention) Post Intervention', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '38'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '37'}]}]}, {'title': 'Baseline (Prevention)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '38'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '37'}]}]}, {'title': '6 Month (Management) Post Intervention', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '28'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '28'}]}]}, {'title': 'Baseline (Management))', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Six months', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'OG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}], 'classes': [{'title': 'Mobile Use (Average Days per Week)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This was not assessed in the paper asthma action plan group.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.36', 'groupId': 'OG001', 'lowerLimit': '2.81', 'upperLimit': '6.51'}]}]}, {'title': 'Paper Use (Average Days per Week)', 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '6.97', 'upperLimit': '7.00'}, {'value': 'NA', 'comment': 'This was not assessed in the mobile phone group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Six months', 'description': '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.', 'unitOfMeasure': 'days per week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'OG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.17', 'groupId': 'OG001', 'lowerLimit': '7.16', 'upperLimit': '16.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Six months', 'description': '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.', 'unitOfMeasure': 'times per week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Mobile phone usage was not assessed in the paper asthma action plan group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'FG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.\n\nPaper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.'}, {'id': 'BG001', 'title': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.\n\nMobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'BG000', 'lowerLimit': '13.4', 'upperLimit': '16.1'}, {'value': '15.3', 'groupId': 'BG001', 'lowerLimit': '14.4', 'upperLimit': '16.8'}, {'value': '15.4', 'groupId': 'BG002', 'lowerLimit': '14.5', 'upperLimit': '16.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2014-01-14', 'resultsFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-03', 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans', 'timeFrame': 'Six months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in Asthma Control Test Scores', 'timeFrame': 'Baseline and Six months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Asthma Self-Efficacy Scores', 'timeFrame': 'Baseline and Six months', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adolescents', 'Asthma', 'Asthma Symptoms'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '17947969', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19221156', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1290773', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10894643', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9556007', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9641931', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9565412', 'type': 'BACKGROUND', 'citation': 'Calmes D, Leake BD, Carlisle DM. Adverse asthma outcomes among children hospitalized with asthma in California. Pediatrics. 1998 May;101(5):845-50. doi: 10.1542/peds.101.5.845.'}, {'pmid': '28111110', 'type': 'DERIVED', 'citation': 'Perry TT, Marshall A, Berlinski A, Rettiganti M, Brown RH, Randle SM, Luo C, Bian J. Smartphone-based vs paper-based asthma action plans for adolescents. Ann Allergy Asthma Immunol. 2017 Mar;118(3):298-303. doi: 10.1016/j.anai.2016.11.028. Epub 2017 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 12 and ≤ 17 years.\n* Access to Apple or Android based smart phone\n* Mild to severe persistent asthma or poorly controlled asthma (see definitions below).\n\n 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.)\n* 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:\n\n * An average of \\>2 days per week with asthma symptoms\n * \\>2 days per week with rescue medication use\n * ≥2 nights per month awakened with nighttime symptoms\n * Minor limitation of activity\n * ≥2 episodes of asthma during the past year that have required systemic corticosteroids\n* 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:\n\n * An average of \\>2 days per week with asthma symptoms\n * \\>2 days per week with rescue medication use\n * ≥2 nights per month awakened with nighttime symptoms\n * Some limitation of activity\n * ≥2 episodes of asthma during the past year that have required systemic corticosteroids.\n\nExclusion Criteria:\n\n* Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.\n* 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.\n* Inability to speak or understand English (child or parent).\n* Children in foster care or other situations in which consent cannot be obtained from a guardian.\n* Prior enrollment in the study.'}, 'identificationModule': {'nctId': 'NCT02091869', 'acronym': 'PEAK2', 'briefTitle': 'A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans', 'orgStudyIdInfo': {'id': '202623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paper Asthma Action Plan', 'description': 'Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.', 'interventionNames': ['Other: Paper Asthma Action Plan']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile Phone', 'description': 'Participants will record asthma symptoms, medication usage, and peak flow data on their phones.', 'interventionNames': ['Device: Mobile Phone']}], 'interventions': [{'name': 'Paper Asthma Action Plan', 'type': 'OTHER', 'description': 'Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.', 'armGroupLabels': ['Paper Asthma Action Plan']}, {'name': 'Mobile Phone', 'type': 'DEVICE', 'otherNames': ['IPhone and Android mobile phones'], 'description': 'Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.', 'armGroupLabels': ['Mobile Phone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Tamara T Perry, MD,FAAP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arkansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}