Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-02 @ 4:33 AM
Study NCT ID:
NCT02417493
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-injection and Self-management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-10', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child comfort with epinephrine self-injection', 'timeFrame': 'Day 1', 'description': 'Immediate pre-post differences within the intervention group in the score obtained on a child-reported "comfort with self-injection" questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Child likelihood of epinephrine self-injection', 'timeFrame': 'Day 1', 'description': 'Immediate pre-post differences within the intervention group in the score obtained on a child-reported likelihood of self-injection questionnaire.'}, {'measure': 'Parent report of child comfort with epinephrine self-injection', 'timeFrame': 'Day 1', 'description': 'Immediate pre-post differences within the intervention group in the score obtained on a parent-reported "child\'s comfort with self-injection" questionnaire.'}, {'measure': 'Child comfort with epinephrine self-injection', 'timeFrame': '1 month post-intervention', 'description': 'Immediate post-1 month post differences between groups in the score obtained on a child-reported "comfort with self-injection" questionnaire.'}, {'measure': 'Parent report of child comfort with epinephrine self-injection', 'timeFrame': '1 month post-intervention', 'description': 'Immediate post- 1 month post differences between groups in the score obtained on a parent-reported "child\'s comfort with self-injection" questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Food allergy', 'self-management', 'epinephrine self-injection', 'ntervention', 'adolescents'], 'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency.', 'detailedDescription': "The purpose of the present study is to determine if asking adolescent patients (ages 13-17) to self-inject an empty syringe into their thigh during routine clinic visits results in increased reported comfort with self-injection, reduced anxiety regarding self-injection and food allergy management for both patient and caregiver(s), and in greater perceived likelihood of epinephrine self-injection, in the event of an emergency. Forty participants, in total, will be recruited during routine visits to an outpatient allergy clinic. Half of all participants will be randomized to the behavioral self-management intervention; whereby patients will insert a needle attached to an empty syringe into their thigh (simulating an injection of epinephrine); the other half of participants will be randomized to the control condition, and will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol. Prior to randomization, baseline measures will be collected on patient's comfort with epinephrine self-injection. Following the self-injection protocol and/or the discussion of self-injection with the physician, all participants will complete immediate post-intervention questionnaires at clinic about comfort with self-injection, health care management and anxiety. One month following the clinic visit, all patients will be sent a follow-up questionnaire that will include items identical to the ones completed at immediate post-intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen in the outpatient clinic and their caretakers (no inpatients).\n* Patients must have been diagnosed with food allergy and previously prescribed self-injectable epinephrine.\n* Patients between the ages of 13-17 years old.\n* Parent consent and child assent.\n\nExclusion Criteria:\n\n* Patients and caregiver(s) who have been diagnosed with cognitive barriers that prevent them from understanding the study, as determined by either: a previously diagnosed mental retardation or inability to repeat the study protocol at the time of consent.'}, 'identificationModule': {'nctId': 'NCT02417493', 'briefTitle': 'Self-injection and Self-management', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Epinephrine Self-injection and Self-management of Food Allergies', 'orgStudyIdInfo': {'id': 'GCO 15-0140'}, 'secondaryIdInfos': [{'id': '02662242 - 4606', 'type': 'OTHER_GRANT', 'domain': 'EMPOWER Program, Mount Sinai Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simulation of Epinephrine Self-Injection', 'description': 'The patient will self-inject an empty syringe into his/her thigh simulating a self-injection of epinephrine during a routine outpatient visit to the allergist.', 'interventionNames': ['Behavioral: Simulation of epinephrine self-injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The patient will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol during a routine outpatient visit to the allergist.'}], 'interventions': [{'name': 'Simulation of epinephrine self-injection', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Simulation of Epinephrine Self-Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Jaffe Food Allergy Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Eyal Shemesh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fordham University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}