Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-18 @ 2:38 PM
Study NCT ID:
NCT03506867
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2018-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy People Initiative (HPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The research staff analyzing the data will be blinded to the allotment and reported outcomes.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The HPI study is a crossover, community-based, multi-site pragmatic RCT (1:1 allocation ratio) in Ottawa and Toronto. It uses a 12-month follow-up to evaluate short- and long-term effects of the intervention on health, social, and economic outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Consent and Protocol Violation Rate', 'timeFrame': '12 months', 'description': 'The consent rate of eligible participants and the rate of protocol violations resulting in cross contamination of the groups receiving study intervention'}, {'measure': 'Healthcare Utilization Rate', 'timeFrame': '12 months', 'description': 'To compare healthcare utilization (ER visits and hospitalizations) over one year before and after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).'}, {'measure': 'Access to Work, Training, and Volunteer Opportunities', 'timeFrame': '12 months', 'description': 'To assess access to work, training, or volunteering positions using a self-reported online survey.'}, {'measure': 'Costs of Poverty Reduction Intervention', 'timeFrame': '12 months', 'description': 'To estimate the costs of poverty reduction intervention (life skills workshops, training, and education/volunteer/employment opportunities.'}, {'measure': 'Average Recruitment Rate', 'timeFrame': '12 months', 'description': 'To assess the ability of participating sites to enroll an average of 6 participants per month.'}, {'measure': 'Poly-substance use rates', 'timeFrame': '12 months', 'description': 'Reductions in polysubstance use (biochemically validated)'}], 'primaryOutcomes': [{'measure': 'Self-Reported Quality of Life', 'timeFrame': '12 Months', 'description': 'To assess the trend in self-reported quality of life using the European Quality of Life 5 Dimensions 5 Level Version.'}], 'secondaryOutcomes': [{'measure': 'Self-Reported Efficacy', 'timeFrame': '12 months', 'description': 'To estimate change in self-reported self-efficacy.'}, {'measure': 'Tobacco use', 'timeFrame': '12 months', 'description': 'To estimate self-reported reduced or quit tobacco use rate (corroborated with the measurement of exhaled Carbon Monoxide) and poly-substance use rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Equity', 'Community Based Participatory Action Research', 'Poverty Reduction'], 'conditions': ['Nicotine Dependence', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'Addictions do not occur in isolation. Tackling addictions requires addressing social determinants such as isolation, homelessness, marginalization, and unemployment. Research on individuals living with or at risk for HIV/AIDS highlights that unemployment correlates with higher levels of depression, anxiety, and social isolation compared to employment. In Ottawa, the PROMPT project engaged homeless or at-risk populations, including people who use drugs and those living with or at risk for HIV/AIDS or Hepatitis C using the Bridge ModelTM, a pragmatic community-based participatory action research approach operationalized through earlier projects at the Bridge Engagement Center in Ottawa, Canada. The PROMPT project demonstrated that implementing multi-component, complex interventions is both feasible and effective, achieving broader socio-economic outcomes beyond reduction and quitting tobacco and poly-substance use. However, PROMPT participants identified a lack of social and recovery capital -family and social connections, opportunities for volunteering and jobs- as a major barrier to recovery. To address this, we conducted a six-month feasibility pilot study with 20 PROMPT participants. By its conclusion, 15 participants were engaged in small paid or volunteer roles, including educational opportunities, fostering both social integration and recovery. Insights from this pilot study informed the design of a larger community-based multi-site pragmatic randomized trial (RCT) to further evaluate the effectiveness of the Bridge ModelTM, the Healthy People Initiative (HPI) project. The Healthy People Initiative (HPI) is a community-based, participatory, pragmatic parallel-arm multi-site with a cross-over design, recruiting 250 participants (16+) at risk of homelessness or low socioeconomic status in Ottawa and Toronto, Canada.', 'detailedDescription': "Title of Trial: A Healthy People Initiative (HPI) - Community-Based Participatory Action Pragmatic Parallel Arm Multi-Site Randomized Controlled Trial using The Bridge ModelTM in Systemically Disadvantaged Populations: HPI Trial Protocol\n\nShort Title of Trial: HPI Trial\n\nPrincipal Investigator: Smita Pakhalé\n\nTrial Sites: Ottawa (The Bridge Engagement Centre) \\& Toronto (Parkdale Activity Recreation Centre)\n\nPrimary outcome: The Healthy People Initiative (HPI) randomized controlled trial (RCT) builds on the pilot study to evaluate changes in participants' self-reported quality of life (QoL) as the primary outcome while implementing the Bridge Model™ approach to address tobacco management.\n\nSecondary outcomes: The secondary objective is to quantify reductions in tobacco use and quitting tobacco use altogether, with quit rates validated biochemically, and changes in self-efficacy.\n\nTertiary outcomes: These include evaluating process-related metrics such as participant enrolment rates, consent rates, and adherence to protocol; estimating implementation costs to guide future cost-effectiveness analyses; and assessing additional patient-reported outcomes such as self-efficacy, participation in education or employment, and reductions in polysubstance use. Additionally, a cost-utility analysis from a health system perspective will assess the economic impact of the 52-week intervention by measuring total costs and healthcare utilization, linking trial data to administrative health records. We aim to provide robust evidence to support the utility of the Bridge ModelTM in addressing health and social inequities through community-driven, peer-led interventions that integrate social determinants with individual health outcomes.\n\nPrimary Objective: To assess the feasibility of a randomized controlled trial investigating access to improvements in 'social capital' in the low income population in Ottawa and Toronto.\n\nStudy Design \\& Population: The HPI study is a crossover, community-based, multi-site pragmatic RCT (1:1 allocation ratio) in Ottawa and Toronto. It uses a 12-month follow-up to evaluate short- and long-term effects of the intervention on health, social, and economic outcomes. Data sources include self-reports, biochemical validation, and administrative health records\n\nSample Size: 250\n\nTrial Arms: The HPI RCT has two arms: usual care and intervention (Figure 1). The intervention arm employs the Bridge ModelTM, offering life-skills workshops, social integration, peer guidance, system navigation (e.g., housing), and APN (Advanced Practice Nurse) or NP (Nurse Practitioner) counselling, including primary care, preventive services, and referrals. Both arms receive monthly follow-ups from peers and APN/NP. Usual care includes resource information and counselling, with an option to switch to the intervention arm after six months. All participants receive nicotine replacement therapy (NRT) for 12 months as needed.\n\nTrial Duration: 12 months Follow-up Duration: 12 months"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 16 years or older, reside in Ottawa or Toronto,\n* Have smoked tobacco in the past 7 days\n* Identify as low socioeconomic status and/or at risk of homelessness, and be available for in-person follow-up for one year.\n\nExclusion criteria:\n\n* Declining consent\n* Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up\n* Currently or recently (in the past 30 days) enrolled in any other smoking cessation program'}, 'identificationModule': {'nctId': 'NCT03506867', 'acronym': 'HPI', 'briefTitle': 'Healthy People Initiative (HPI)', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Healthy People Initiative (HPI) - Community-Based Participatory Action Pragmatic Parallel Arm Multi-Site Randomized Controlled Trial Using The Bridge ModelTM in Systemically Disadvantaged Populations: HPI Trial Protocol', 'orgStudyIdInfo': {'id': '20180274-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care arm', 'description': 'We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.', 'interventionNames': ['Behavioral: Life skills, training, education and work/volunteer opportunities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Life skills, training, education and work/volunteer opportunities, and peer support', 'description': 'The life skills, training, education, work/volunteer opportunities, and peer support arm will be offered to the usual care arm participants after the first six months of study enrollment.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Life skills, training, education and work/volunteer opportunities', 'type': 'BEHAVIORAL', 'description': 'Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).', 'armGroupLabels': ['Usual care arm']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.', 'armGroupLabels': ['Life skills, training, education and work/volunteer opportunities, and peer support']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1K 4B7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Bridge Engagement Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Smita Pakhalé, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Upon request study de-identified data will be made available to interested and qualified researchers. No time frame necessary.', 'ipdSharing': 'YES', 'description': 'Upon request study de-identified data will be made available to interested and qualified researchers.', 'accessCriteria': 'No access criteria. De-identified raw data will be available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}