跳至主要内容
临床试验/NCT04271371
NCT04271371已完成不适用

Preventing Relapse to Smoking Among Prisoners After Release: Developing and Piloting a Complex Health Intervention

University of Nottingham1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.

研究概览

简要总结

Prisoners experience huge health inequalities, and their exceptionally high smoking prevalence (five times the national average) contributes significantly to their high mortality. Since the introduction of smoke-free polices across Her Majesty's Prison and Probation Service (HMPPS) in England and Wales, prisoners are now obliged to abstain from smoking while held in prison. This represents a unique opportunity to promote lifelong cessation in this highly disadvantaged and marginalised group. However, evidence suggests most prisoners intend to resume smoking as soon as possible after release. A systematic review of prison smoke-free polices worldwide concluded that there was a need for new research to identify effective strategies to reduce relapse in these individuals.

详细描述

The primary objective of this study will be to develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release. The study will work in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The Preventing Relapse tO Smoking among PrisonErs after Release (PROSPER) study consists of three key Phases:

  1. Document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release; establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release; and obtain views on how relapse might be prevented.
  2. Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.
  3. To pilot the designed prototype intervention and conduct a process evaluation to inform the development of further work in this area.

The research will be carried out in three prisons in the East Midlands. The main duties will include recruitment of participants (HMPPS staff members and prisoners), data collection, data analysis, assist with intervention development and refining related intervention materials/resources, co-facilitate Patient and Public Involvement (PPI) groups, contribute to the ethical application for the pilot intervention, and preparation of manuscripts for peer-review publication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.

时间窗: 3 years

Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.

次要结局

  • To document prisoners smoking history to date and levels of nicotine addiction.(1 year)
  • The impact of smoke-free prison policy on prisoners smoking behaviours.(1 year)
  • To establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release (and does their intended behaviour pre-release predict post-release behaviour).(1 year)
  • To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.(1 year)
  • To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.(1 year)
  • To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.(1 year)
  • After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.(1 year)
  • Record and examine other potential predictors (as outlined in the international literature) of relapse to smoking after release from smoke-free prisons, e.g other negative health behaviours.(1 year)
  • To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.(1 year)
  • For those prisoners who return to smoking after release, at what point do they resume smoking (in days).(1 year)
  • For those prisoners who do return to smoking after release, do they smoke less, the same or more as they previously smoked before entering prison/and or before the prison service went smoke-free.(1 year)
  • Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).(1 year)
  • To identify aspects of the intervention and delivery that could be improved.(1 year)
  • Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.(1 year)
  • Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.(1 year)
  • To develop logic models to map the problem and the prototype intervention.(1 year)
  • To assess any barriers and facilitators to the developed intervention.(1 year)
  • To explore any unintended consequences as a result of the intervention.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验