Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02302859
Status:
TERMINATED
Last Update Posted:
2020-01-27
First Post:
2014-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmcneill@mdanderson.org', 'phone': '713- 563-1103', 'title': 'Dr. Lorna McNeill, MPH,PHD/ Chair, Health Disparities Research', 'organization': 'The University of Texas (UT) MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small number of subjects registered, study halted without analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data collected over 3 month treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Treatment (ST)', 'description': 'Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Automated Treatment (AT)', 'description': 'Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Abstinence: 3-month Assessment Via Smart Phone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment (ST)', 'description': 'Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.'}, {'id': 'OG001', 'title': 'Automated Treatment (AT)', 'description': 'Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.'}], 'timeFrame': '3 months', 'description': 'Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected due to early termination of the protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Treatment (ST)', 'description': 'Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.'}, {'id': 'FG001', 'title': 'Automated Treatment (AT)', 'description': 'Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost Phone', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment Period Opened January 2015 and Closed March 2016. Recruitment was accomplished in clinic setting of a large comprehensive HIV-care center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Treatment (ST)', 'description': 'Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.'}, {'id': 'BG001', 'title': 'Automated Treatment (AT)', 'description': 'Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '48'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '57'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'At the request of the PI', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2014-11-21', 'resultsFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-23', 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Abstinence: 3-month Assessment Via Smart Phone', 'timeFrame': '3 months', 'description': 'Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer Prevention', 'Tobacco Use Cessation', 'HIV-positive', 'Nicotine patch', 'NRT', 'Questionnaire', 'Survey', 'Smartphone', 'Counseling', 'Saliva test', 'Saliva cotinine test', 'Nicotine replacement therapy', 'Smoking abstinence', 'Aids'], 'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.', 'detailedDescription': 'Baseline Questionnaire:\n\nIf you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.\n\nStudy Groups:\n\nAfter completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.\n\nBoth groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.\n\nIf you are assigned to Group 1, the following study procedures will be performed:\n\n* You will receive brief advice on how to quit smoking once at the time of enrollment. The advice will be given from a pamphlet that has information such as health problems related to smoking, how many Americans are affected each year, financial problems related to smoking, nicotine replacement therapy options, preparation for quitting smoking, and encouragement to quit.\n* On the smart phone, you will have 5 phone counseling sessions for support in quitting smoking throughout the 8-week intervention treatment. The calls should last about 15 minutes.\n\nIf you are assigned to Group 2, the following study procedures will be performed:\n\n* On the smart phone, you will receive brief video clips with advice on how to quit smoking, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.\n* You will also have access to additional counseling content on the smart phone, which you can use at any time.\n\nWeekly Smart Phone Questionnaires:\n\nBoth groups will complete questionnaires on the smart phone every week for 8 weeks. Each questionnaire will have questions about your current smoking status, your motivation level to stop smoking, and things that may have a negative effect on your quitting. The questionnaire should take about 15 minutes to complete.\n\nFollow-up Saliva Test and Questionnaire:\n\nAbout 3 months after your first smart phone intervention, both groups will complete a saliva test and take a photograph of the test results. The saliva test results will be used to check your smoking activity. Supplies and instructions will be given to you when you are enrolled on the study and the instructions will be available on the smart phone. You will also complete a questionnaire similar to the baseline questionnaire.\n\nLength of Study:\n\nYou will be on study for about 3 months.\n\nThis is an investigational study. Up to 50 participants will take part in this study. All will be enrolled at the Harris Health System (Thomas Street Health Center).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. Smoked at least 100 cigarettes in lifetime\n3. English speaking\n4. HIV-positive patient at Thomas Street Health Center\n5. Currently smoking 5 or more cigarettes per day\n6. Willing to make a quit attempt within 1 week of enrollment\n\nExclusion Criteria:\n\n1. Positive history of a medical condition that precludes use of the nicotine patch\n2. Current use of nicotine replacement therapy (NRT)\n3. Current use of other smoking cessation medications (e.g., Chantix or Zyban)\n4. Pregnant or nursing\n5. Enrolled in another smoking cessation study'}, 'identificationModule': {'nctId': 'NCT02302859', 'briefTitle': 'Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study', 'orgStudyIdInfo': {'id': '2014-0509'}, 'secondaryIdInfos': [{'id': 'NCI-2014-02572', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Treatment (ST)', 'description': 'Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.\n\nParticipants receive weekly assessments to complete for the 8-week treatment period via smartphone.\n\nParticipants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.\n\nParticipants complete saliva cotinine test 3 months after intervention.', 'interventionNames': ['Drug: Nicotine Patch', 'Behavioral: Questionnaires', 'Other: Pamphlet', 'Behavioral: Phone Counseling Sessions', 'Other: Saliva Test', 'Device: Smart phone']}, {'type': 'EXPERIMENTAL', 'label': 'Automated Treatment (AT)', 'description': 'Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.\n\nParticipants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.\n\nParticipants complete saliva cotinine test 3 months after intervention.', 'interventionNames': ['Drug: Nicotine Patch', 'Behavioral: Questionnaires', 'Behavioral: Phone Counseling Sessions', 'Other: Saliva Test', 'Device: Smart phone']}], 'interventions': [{'name': 'Nicotine Patch', 'type': 'DRUG', 'otherNames': ['NRT'], 'description': 'Participants receive an 8 week supply of Nicotine patches.', 'armGroupLabels': ['Automated Treatment (AT)', 'Standard Treatment (ST)']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention.', 'armGroupLabels': ['Automated Treatment (AT)', 'Standard Treatment (ST)']}, {'name': 'Pamphlet', 'type': 'OTHER', 'description': 'Pamphlet given to participant describing health and financial reasons to quit smoking.', 'armGroupLabels': ['Standard Treatment (ST)']}, {'name': 'Phone Counseling Sessions', 'type': 'BEHAVIORAL', 'description': 'Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes.\n\nAutomated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.\n\nParticipants also have access to additional counseling content on the smart phone, which can be used at any time.', 'armGroupLabels': ['Automated Treatment (AT)', 'Standard Treatment (ST)']}, {'name': 'Saliva Test', 'type': 'OTHER', 'description': 'Participants complete saliva cotinine test 3 months after intervention.', 'armGroupLabels': ['Automated Treatment (AT)', 'Standard Treatment (ST)']}, {'name': 'Smart phone', 'type': 'DEVICE', 'description': 'Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.\n\nAutomated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.', 'armGroupLabels': ['Automated Treatment (AT)', 'Standard Treatment (ST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Health Center -Harris Health System', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Diana S. Hoover, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}