Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05553951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-20
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence in Global Airways
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-06', 'size': 261862, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-09-21T14:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MARS-5 L/N - Medication adherence report scale both for upper and lower airways', 'timeFrame': '4 months', 'description': 'Min. 0 point= non adherent, max. 25 point=adherent'}], 'secondaryOutcomes': [{'measure': 'SNOT-22 - The Sino-Nasal Outcome Test 22', 'timeFrame': '4 months', 'description': 'min. 0 point=no symptoms, max. 110 point=many symptoms.'}, {'measure': 'miniAQLQ - Mini asthma quality of life questionnaire', 'timeFrame': '4 months', 'description': 'min. 1= all the time, max. 7= not at all'}, {'measure': 'HADS - Hospital Anxiety and Depression Scale', 'timeFrame': '4 months', 'description': 'Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression'}, {'measure': 'STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)', 'timeFrame': '4 months', 'description': 'There is no minimum or maximum yet'}, {'measure': 'ACT - Asthma Control Test', 'timeFrame': '4 months', 'description': 'min. 5 (poor control of asthma), max. 25 (complete control of asthma),'}, {'measure': 'ACQ-7 - Asthma Control Questionnaire', 'timeFrame': '4 months', 'description': 'min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er \\> 1.5'}, {'measure': 'ESS - EPWORTH SLEEPINESS SCALE', 'timeFrame': '4 months', 'description': 'min=0 point= normal sleep, max. 24 point= severe sleepiness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence', 'Nurse', 'Global airways', 'Astma', 'Chronic Rhinosinusitis with Nasal Polyps'], 'conditions': ['Chronic Rhinosinusitis Without Nasal Polyps', 'Asthma', 'Chronic Rhinosinusitis With Nasal Polyps', 'Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS.\n\nSeveral studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS.\n\nAim:\n\nTo investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence.\n\nHypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care.\n\nIn a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance.\n\nPrimary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance.\n\nInclusion Criteria:\n\nAdherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), \\>18 years of age, SNOT-22 score ≥35\n\nExclusion Criteria:\n\n* Adherence to MARS-5- L/N \\>35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities\n\nQuestionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adherence to MARS- 5 L/N ≤35 at first visit\n* Diagnosed with asthma (with and without allergic rhinitis) at initial visit\n* Able to use smartphone\n* ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma)\n* Be over 18 years of age\n* SNOT-22 score ≥35\n* Diagnosed with CRSwNP\n\nExclusion Criteria:\n\n* Adherence to MARS-5- L/N \\>35 points at first visit\n* Do not have smartphone\n* Does not read or speak English\n* Other illness requiring regular medication\n* Pregnancy and pregnancy that started during the study time period\n* Servere psychological comorbidities'}, 'identificationModule': {'nctId': 'NCT05553951', 'acronym': 'AIR2022', 'briefTitle': 'Adherence in Global Airways', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care', 'orgStudyIdInfo': {'id': '2022-ENT-2- adherence'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventions group', 'description': 'will receive systematic and structured nursing supervison about their adherence', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Will receive usual care', 'interventionNames': ['Behavioral: Controlgroup']}], 'interventions': [{'name': 'Controlgroup', 'type': 'BEHAVIORAL', 'description': 'The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.', 'armGroupLabels': ['Control group']}, {'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Patients in the intervention group will receive systematic and structured nursing guidance regarding their adherence, which includes proper use of nasal irrigation once or twice daily, nasal steroid/drops, use of inhaled medications, follow-up of smoking status. The intervention group will receive guidance videos which have been prepared prior to the study and will be standard for the intervention group. Guidance videos will cover the correct use of nasal irrigation, inhalation steroid, and nasal steroid/drops.', 'armGroupLabels': ['Interventions group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Otorhinolaryngology, Head and Neck Surgery & Audiology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Vibeke P Backer', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiane Haase', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical nurse specialist and Phd-student', 'investigatorFullName': 'Christiane Haase', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}