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临床试验/NCT03506867
NCT03506867Enrolling By Invitation不适用

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

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
250
试验地点
2
主要终点
Self-Reported Quality of Life

研究概览

简要总结

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.

详细描述

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

Short Title of Trial: HPI Trial

Principal Investigator: Smita Pakhalé

Trial Sites: Ottawa (The Bridge Engagement Centre) & Toronto (Parkdale Activity Recreation Centre)

Primary 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The research staff analyzing the data will be blinded to the allotment and reported outcomes.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be 16 years or older, reside in Ottawa or Toronto,
  • Have smoked tobacco in the past 7 days
  • Identify as low socioeconomic status and/or at risk of homelessness, and be available for in-person follow-up for one year.
  • Exclusion criteria:
  • Declining consent
  • 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
  • Currently or recently (in the past 30 days) enrolled in any other smoking cessation program

排除标准

  • 未提供

结局指标

主要结局

Self-Reported Quality of Life

时间窗: 12 Months

To assess the trend in self-reported quality of life using the European Quality of Life 5 Dimensions 5 Level Version.

次要结局

  • Self-Reported Efficacy(12 months)
  • Tobacco use(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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