Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT04657250
Status:
WITHDRAWN
Last Update Posted:
2022-11-08
First Post:
2020-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mHealth for Smoking Cessation in Public Housing
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants making a quit attempt', 'timeFrame': '3 months', 'description': 'not smoking for 24 hours or more because trying to quit smoking'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who quit smoking', 'timeFrame': '3 months', 'description': 'self reported 7 day point prevalence abstinence'}, {'measure': 'Number of cigarettes smoked per day', 'timeFrame': '3 months', 'description': 'change in number of cigarettes smoked per day between baseline and follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile phone', 'mHealth', 'text messaging'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Smoking rates among public housing residents are more than twice as high as in the general population. In August 2018, the U.S. Department of Housing and Urban Development (HUD) required all public housing in the U.S. to become smoke-free. While HUD recommended that Public Housing Authorities provide smoking cessations services, at present, the D.C. Housing Authority (DCHA) does not offer any cessation services to its residents. Low-income smokers face unique challenges to smoking cessation and require sustained support for smoking cessation. Digital interventions such as text messaging programs and quitline (QL) phone counseling are scalable, evidence-based interventions for smoking cessation that can provide support over an extended timeframe at low cost.\n\nThe aim of this proposed research is to conduct a feasibility trial to assess the acceptability, levels of engagement, and preliminary efficacy of an integrated program that combines text-messaging for smoking cessation and text messages providing proactive linkage to the quitline compared to a single passive quitline text message referral among DCHA residents. The investigators hypothesize that the integrated program (combining text messages for smoking cessation and proactive quitline linkage) will yield significantly higher rates of quit attempts than passive quitline referral only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* resident of D.C. public housing\n* smoked a cigarette in the 7 days prior to screening (self-report)\n* has daily access to a working cell phone with an unlimited text message plan\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04657250', 'briefTitle': 'mHealth for Smoking Cessation in Public Housing', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'mHealth for Smoking Cessation in Public Housing', 'orgStudyIdInfo': {'id': 'NCR191457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smoking cessation + quitline linkage text messages', 'description': 'Text messaging for smoking cessation + text messages with proactive linkage to quitline', 'interventionNames': ['Behavioral: Smoking cessation + quitline linkage text messages']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Passive quitline referral', 'description': 'Single text message with contact information for the Quitline', 'interventionNames': ['Behavioral: Passive quitline referral']}], 'interventions': [{'name': 'Smoking cessation + quitline linkage text messages', 'type': 'BEHAVIORAL', 'description': 'Smoking cessation text messages will provide behavioral skills and support for quitting smoking. Quitline linkage text messages will include contact information for the quitline, option to be contacted by the quitline and active referral to the quitline upon setting a Quit Date.', 'armGroupLabels': ['Smoking cessation + quitline linkage text messages']}, {'name': 'Passive quitline referral', 'type': 'BEHAVIORAL', 'description': 'Single text message with contact information for the Quitline', 'armGroupLabels': ['Passive quitline referral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Lorien Abroms', 'investigatorAffiliation': 'George Washington University'}}}}