- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271371
Preventing Relapse to Smoking Among Prisoners After Release (PROSPER)
Preventing Relapse to Smoking Among Prisoners After Release: Developing and Piloting a Complex Health Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- 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.
- Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Please Select
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Nottingham, Please Select, United Kingdom, NG5 1PB
- University of Nottingham, School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria 2. Release prisoner cohort
- All participants are aged 18 or over (no upper age limit)
- Are currently residing in one of the three study sites (HMPs Nottingham, Ranby and Sudbury)
- Male (women will not be held at any of the study sites)
- Have a provisional release date within the next 2 months.
- Are capable of understanding and consenting to the study.
- Remand and sentenced prisoners.
Who report that they are a current smoker and/or a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.
3. Reception prisoner cross-sectional
- All participants are aged 18 or over (no upper age limit)
- Are currently residing in the open prison study site (HMP Sudbury)
- Male (women will not be held at any of the study sites)
- Have been in the open prison more than two weeks but for less than 3 months.
- Have been transferred from a closed prison.
- Are capable of understanding and consenting to the study.
- Sentenced prisoners.
- Who report that they were a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.
Exclusion criteria 2. Release prisoner cohort
- Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
- Non-smokers.
- Being deported post release.
Been in prison for less than four weeks.
3. Reception prisoner cross-sectional
- Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
- Been in prison for less than 2 weeks.
- Non-smokers.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Prototype intervention
To be developed through Phase 1 and 2
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A prototype intervention will be developed over Phase 1 & 2 and piloted in Phase 3 of this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.
Time Frame: 3 years
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Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To document prisoners smoking history to date and levels of nicotine addiction.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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The impact of smoke-free prison policy on prisoners smoking behaviours.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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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).
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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For those prisoners who return to smoking after release, at what point do they resume smoking (in days).
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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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.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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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.
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).
Time Frame: 1 year
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Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
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1 year
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To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.
Time Frame: 1 year
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Phase 2 (Intervention development)
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1 year
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To develop logic models to map the problem and the prototype intervention.
Time Frame: 1 year
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Phase 2 (Intervention development)
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1 year
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To assess any barriers and facilitators to the developed intervention.
Time Frame: 1 year
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Phase 3 (Intervention pilot & Intervention process evaluation)
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1 year
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To explore any unintended consequences as a result of the intervention.
Time Frame: 1 year
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Phase 3 (Intervention pilot & Intervention process evaluation)
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1 year
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To identify aspects of the intervention and delivery that could be improved.
Time Frame: 1 year
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Phase 3 (Intervention pilot & Intervention process evaluation)
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1 year
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Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.
Time Frame: 1 year
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Phase 3 (Intervention pilot & Intervention process evaluation)
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1 year
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Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.
Time Frame: 1 year
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Phase 3 (Intervention pilot & Intervention process evaluation)
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 254028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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