Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06742320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Education Given to Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Children will be randomly assigned to the training and control groups via a computer program.This process was carried out by a person other than the researchers.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is an experimental type with a pre-test, post-test and follow-up test control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Quality of Life Scale for Children', 'timeFrame': 'About 3 months', 'description': "The scale was developed for children aged 7-11 and adapted to Turkish by Yüksel et al. (2009) and consists of 3 sub-dimensions, namely 'asthma symptoms', 'activity limitation' and 'emotional function', and 23 questions. Scoring varies between 1-7 for each item.The total score to be obtained from the scale is between 23 and 161. A high score indicates a good quality of life."}, {'measure': 'Childhood Asthma Control Test', 'timeFrame': 'About 3 months', 'description': "The scale evaluates asthma symptoms in the last 4 weeks for children aged 4-11. Children answer the first 4 questions themselves, while the person responsible for the child's care answers the last 3 questions. The total score to be obtained from the scale is between 0-27. Patients with a total score of 19 points and below are considered to have uncontrolled asthma, and patients with a score of 20 points and above are considered to have controlled asthma."}], 'secondaryOutcomes': [{'measure': 'Asthma Knowledge Survey', 'timeFrame': 'About 3 months', 'description': "The asthma knowledge survey, which was created by the researchers by reviewing the relevant literature, consists of 13 questions. The first 8 questions in the survey are about asthma definition, symptoms, triggers and physical activity status, and the last 5 questions are about asthma treatment. The questions have a 3-point answer option of yes, no/I don't know. 1 point is received for correct answers and 0 points are received for wrong/I don't know. There is a total distribution between 0-13 points. The survey items were rearranged in line with the opinions received from 9 experts. The content validity rates of the scores given by the experts to the items vary between 0.85-1.0. The content validity index was calculated as 0.98 in the study. It was determined that there was a high level and statistically significant consensus among the experts."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'children', 'education', 'randomized control'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.', 'detailedDescription': "Asthma is among the most common chronic diseases in childhood. Besides being one of the most common diseases, it is a preventable and controllable disease.In a study analyzing asthma data of children aged 0-17 by the Centers for Disease Control and Prevention (CDC), the prevalence of asthma was 8.7% in 2001, this rate increased to 9.4% in 2010, and decreased to 8.3% in 2016. In the same study, the prevalence of asthma was found to be 9.2% in boys and 7.4% in girls.Asthma is also the leading cause of school absences in children ages 5 to 17, accounting for more than 14 million days of absence from school in 2013.These adverse effects of asthma can be minimized with appropriate education.Studies have found an increase in the quality of life of asthmatic students after asthma education, a decrease in asthma exacerbations, school absences, parental workday loss and medical expenses, and an increase in adherence to treatment, asthma knowledge and correct inhaler use.These findings suggest that asthma management interventions increase children's knowledge about their disease and their self-management skills.Based on this need, the aim of this study is to examine the effects of asthma education given to school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic on their asthma knowledge, control and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 7-11,\n* Medically diagnosed with asthma and being followed up in the outpatient clinic\n* Family and child agreeing to participate in the study\n* Ability to use a smartphone, computer or tablet\n* Having internet access\n* Children who can read and understand Turkish\n\nExclusion Criteria:\n\n* Children who do not have a medical diagnosis of asthma\n* Children who do not agree to participate in the study and their parents\n* Children who do not complete the training and tests'}, 'identificationModule': {'nctId': 'NCT06742320', 'acronym': 'RCT', 'briefTitle': 'The Effect of Education Given to Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Effect of Education on Asthma Knowledge, Control and Quality of Life in School-Age Children Diagnosed With Asthma', 'orgStudyIdInfo': {'id': '2024/10-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education Group', 'description': 'Pre-test forms were applied to the children in the training group face to face by the researchers in the outpatient clinic. Children assigned to the training group received asthma education in a single session, 3 modules/each module lasting at least 15 minutes. Post-test forms were administered immediately after the training.The 2nd and 3rd follow-up tests will be administered online via Google Form in the 1st and 3rd months after the training is completed.', 'interventionNames': ['Behavioral: Asthma education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Pre-test forms will be applied to the control group face-to-face by researchers in the outpatient clinic.In the control group, follow-up tests (three weeks, 1 month and 3 months after the pre-tests) will be administered online via Google Form.'}], 'interventions': [{'name': 'Asthma education', 'type': 'BEHAVIORAL', 'description': 'There are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey.', 'armGroupLabels': ['Education Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35330', 'city': 'Izmir', 'state': 'Balcova', 'country': 'Turkey (Türkiye)', 'facility': "Dokuz Eylul University Nevvar & Salih İşgören Children's Hospital Pediatric Allergy and Immunology Polyclinic", 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "I haven't decided yet."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist nurse', 'investigatorFullName': 'Atiye Yıldırım', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}