Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
Study NCT ID:
NCT05415761
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2022-06-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomized to one of the 3 study arms, using a 1:1:1 allocation scheme'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1332}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Point-Prevalence Abstinence (PPA)', 'timeFrame': 'Month 6', 'description': 'negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days'}], 'secondaryOutcomes': [{'measure': 'Smoking Point-Prevalence Abstinence (PPA)', 'timeFrame': 'Months 2 and 12', 'description': 'negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'Month 12', 'description': '5-item scale measuring treatment by interest, usefulness, concern with privacy, how easy to understand, and satisfaction. Items will be measured on a 0-10 point scale, with higher scores corresponding to greater acceptability.'}, {'measure': 'Quality of Life and Well-Being', 'timeFrame': 'Baseline, and month 6', 'description': 'World Health Organization Quality of Life-BREF (WHOQOL-BREF): 26-item scale that measures quality of life. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with a higher score indicating a higher quality of life.'}, {'measure': 'Self Efficacy', 'timeFrame': 'Baseline, and month 6', 'description': 'Self-Efficacy Questionnaire (SEQ-12): 12-item scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores indicating greater self-efficacy.'}, {'measure': 'Acceptance', 'timeFrame': 'Months 2 and 6', 'description': '9-item physical sensations subscale of the Avoidance and Inflexibility Scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores reflecting more inflexibility/avoidance in the presence of difficult smoking-related thoughts, feelings, and sensations.'}, {'measure': 'Values', 'timeFrame': 'Months 2 and 6', 'description': 'Valuing Questionnaire (VQ): 10-item measure assessing the extent to which one lives consistently with their values, including Progress and Obstruction subscales. Both subscales total scores range from 0 to 30. A psychologically healthier score is indicated by a higher score on the Progress scale along with a lower score on the Obstructions scale.'}, {'measure': 'Motivation', 'timeFrame': 'Months 2 and 6', 'description': 'Motivational Engagement Questionnaire: 5-item measure. Items are rated on a 7-point Likert scale (low score of 1 to high score of 7), with higher scores indicating more motivation to quit smoking.'}, {'measure': 'Smoking Prolonged Abstinence', 'timeFrame': 'Months 6 and 12', 'description': 'Self-reported abstinence from the date of the last time a cigarette was smoked.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tobacco use intervention', 'mobile health aids'], 'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'references': [{'pmid': '36804046', 'type': 'DERIVED', 'citation': 'Salloum RG, Bricker JB, Lee JH, Theis RP, Pluta K, Williams MP, Naous J, Mulani SR, Cogle CR, Rubin DA, Fahnlander AM, Nordelo B, Sullivan BM, Bloodworth S, Corbin L, Siler K, Willis D, Carrasquillo O, Dallery J. Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial. Contemp Clin Trials. 2023 Apr;127:107120. doi: 10.1016/j.cct.2023.107120. Epub 2023 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.', 'detailedDescription': "The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥21 years old\n* Referred by the provider via Ask-Advise-Connect\n* Receiving care at one of the participating clinics\n* Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)\n* No household members already enrolled\n\nExclusion Criteria:\n\n* Unstable medical or psychiatric illness'}, 'identificationModule': {'nctId': 'NCT05415761', 'acronym': 'PROMOTE-UP', 'briefTitle': 'Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care', 'orgStudyIdInfo': {'id': 'IRB202200918'}, 'secondaryIdInfos': [{'id': 'OCR41824', 'type': 'OTHER', 'domain': 'UF OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iCanQuit', 'description': "iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.", 'interventionNames': ['Behavioral: iCanQuit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'iCanQuit+Motiv8', 'description': "Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.", 'interventionNames': ['Behavioral: iCanQuit+Motiv8']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Florida quit line', 'description': 'The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.', 'interventionNames': ['Behavioral: Florida quit line']}], 'interventions': [{'name': 'iCanQuit', 'type': 'BEHAVIORAL', 'description': 'iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment', 'armGroupLabels': ['iCanQuit']}, {'name': 'iCanQuit+Motiv8', 'type': 'BEHAVIORAL', 'description': 'iCanQuit + Motiv8 is a integrated version of iCanQuit (Cognitive Behavioral Therapy smoking cessation therapy application) with Motiv8 (a contingency management program that rewards decreased smoking determined by measuring CO levels of participant)', 'armGroupLabels': ['iCanQuit+Motiv8']}, {'name': 'Florida quit line', 'type': 'BEHAVIORAL', 'description': 'An evidence-based, existing smoking cessation healthcare option recommended by the U.S. clinical practice that connects active smokers to trained quit coaches via referral by their providers.', 'armGroupLabels': ['Florida quit line']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Dwarka', 'role': 'CONTACT', 'email': 'dwarkaa12@ufl.edu', 'phone': '352-294-8417'}, {'name': 'Jesse Dallery, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Jesse Dallery, PhD', 'role': 'CONTACT', 'email': 'dallery@ufl.edu', 'phone': '352-273-2182'}, {'name': 'Ramzi Salloum, PhD', 'role': 'CONTACT', 'email': 'rsalloum@ufl.edu', 'phone': '352-294-4997'}], 'overallOfficials': [{'name': 'Jesse Dallery, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Ramzi Salloum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}