Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05148520
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Provision of Service of a YQL Programme For Youth Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported 7-point prevalence', 'timeFrame': 'at the 6-month follow-up', 'description': 'The self-reported abstinence will be validated if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking cessation service', 'youth smoker'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months. It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.', 'detailedDescription': 'This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022). Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors. We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 25 or below\n* Self-reported to smoke any types of tobacco products within the past 1 month\n* Speak Cantonese and\n* Provide verbal consent to counselling service.\n\nExclusion Criteria:\n\n* have psychiatric disease\n* and/or currently receive any smoking cessation intervention from other service providers'}, 'identificationModule': {'nctId': 'NCT05148520', 'briefTitle': 'Provision of Service of a YQL Programme For Youth Smokers', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Provision of Service of a Youth Quitline Programme For Youth Smokers', 'orgStudyIdInfo': {'id': 'YQL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "5A's model", 'description': "The practice guideline emphasizes on the use of '5A's' model that contains five major steps in providing smoking cessation counselling. Specifically, our counsellors will take the following steps to provide telephone counselling for youth smokers who are ready to quit smoking", 'interventionNames': ["Behavioral: 5A's model"]}], 'interventions': [{'name': "5A's model", 'type': 'BEHAVIORAL', 'description': '(1) Ask - ask youth smokers about their smoking habit, (2) Advise - advise youth smokers to quit smoking, (3) Assess - assess youth smokers about their willingness to quit smoking, (4) Assist - assist youth smokers who are willing to make a quit attempt, and (5) Arrange\n\n\\- arrange for follow-up.', 'armGroupLabels': ["5A's model"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Hong Kong,China', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ka Yan Ho, Phd', 'role': 'CONTACT', 'email': 'kyeva.ho@polyu.edu.hk', 'phone': '27666417'}], 'facility': 'Ka Yan Ho', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Ka Yan Ho, PhD', 'role': 'CONTACT', 'email': 'kyeva.ho@polyu.edu.hk', 'phone': '27666417'}, {'name': 'Ka Wai Lam, PhD', 'role': 'CONTACT', 'email': 'kwkatlam@polyu.edu.hk', 'phone': '27666420'}], 'overallOfficials': [{'name': 'Ka Yan Ho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Eva Ho', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}