Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-06 @ 8:30 PM
Study NCT ID:
NCT05461066
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': 'Before/after the intervention (1 year)', 'description': 'Dichotomicus variable (yes/no)'}, {'measure': 'Quality of Life (EuroQOL-5D)', 'timeFrame': '1 year', 'description': 'Measured with EuroQOL-5D'}, {'measure': 'Cost-effectiveness', 'timeFrame': '1 year', 'description': 'In cost-effectiveness, the deterministic Incremental Cost Effectiveness Ratio (ICER) is the coefficient resulting from dividing the difference between groups in costs by the difference in probability between groups that an additional patient will cease their smoking history.'}, {'measure': 'Cost-utility', 'timeFrame': '1 year', 'description': 'For the cost-utility, the Deterministic Incremental Cost-Utility Ratio (ICUR) is the coefficient resulting from dividing the difference between groups in costs by the difference between groups in quality-adjusted life years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Pharmacist-Patient Relations']}, 'referencesModule': {'references': [{'pmid': '37704533', 'type': 'DERIVED', 'citation': "Gomez Martinez JC, Gaztelurrutia Lavesa L, Mendoza Barbero A, Plaza Zamora J, Lage Pinon M, Aguilo Juanola M, Climent Catala M, de Andres Dirube A, Garcia Moreno L, Jaraiz Magarinos I, Moral Ajado M, Sanchez Marcos N. Smoking cessation intervention in the community pharmacy: Cost-effectiveness of a non-randomized cluster-controlled trial at 12-months' follow-up. Res Social Adm Pharm. 2024 Jan;20(1):19-27. doi: 10.1016/j.sapharm.2023.09.003. Epub 2023 Sep 7."}]}, 'descriptionModule': {'briefSummary': "The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoker over 18 years old\n* consent to participate\n* presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.\n\nExclusion Criteria:\n\n* cognitive impairment\n* drug uses\n* pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT05461066', 'acronym': 'CESAR', 'briefTitle': 'Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria'}, 'officialTitle': "Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up", 'orgStudyIdInfo': {'id': 'EPA-13-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Smoking cessation intervention in community pharmacies', 'interventionNames': ['Behavioral: CESAR training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Usual care of smoking cessation in community pharmacies', 'interventionNames': ['Behavioral: CESAR training']}], 'interventions': [{'name': 'CESAR training', 'type': 'BEHAVIORAL', 'description': 'Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}