Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:53 PM
Study NCT ID:
NCT05000606
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2021-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Home Visit Program and Perceived Care Burden
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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zarit Caregiver Burden Scale', 'timeFrame': 'Baseline', 'description': 'The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.'}, {'measure': 'Zarit Caregiver Burden Scale', 'timeFrame': 'Change from Baseline Perceived Care Burden Scores at 1 month', 'description': 'The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.'}, {'measure': 'Zarit Caregiver Burden Scale', 'timeFrame': 'Change from 1 month Perceived Care Burden Scores at 3rd months', 'description': 'The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'burden', 'caregiver', 'education', 'home visit'], 'conditions': ['Burden']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.', 'detailedDescription': 'The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group. A total of five home visits over three months were performed. Data were collected by a personal information form, and the Zarit Caregiver Burden Scale (ZCBS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* giving care to a patient who was poorly controlled or uncontrolled asthma\n* giving care to a patient who used an inhaler\n* age 18 or over\n* volunteering to participate to the study\n\nExclusion Criteria:\n\n* having a disease with a neuro-psychiatric diagnosis\n* having vision and hearing problems'}, 'identificationModule': {'nctId': 'NCT05000606', 'briefTitle': 'A Home Visit Program and Perceived Care Burden', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effect of a Home Visit Program for Caregivers of Asthmatic Patients on Perceived Care Burden', 'orgStudyIdInfo': {'id': '77082166-604.01.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A home visit program', 'description': 'A home visit program including five visits over three months were performed.', 'interventionNames': ['Other: A home visit program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No other intervention was applied to the control group other than the standard education given in the outpatient clinic'}], 'interventions': [{'name': 'A home visit program', 'type': 'OTHER', 'description': 'A home visit program including education and counseling was applied. A total of five home visits over three months were performed.', 'armGroupLabels': ['A home visit program']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Faculty of Nursing, Nursing Department', 'investigatorFullName': 'Sultan Ayaz Alkaya', 'investigatorAffiliation': 'Gazi University'}}}}