- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267936
Interventions for Maximizing Patient And Family Smoking Cessation Together (IMPACT)
This feasibility study evaluates the effectiveness of a household-based smoking cessation intervention for patients and their household members. Patients who smoke and live with household members who also smoke will be invited to participate in the Treating Tobacco Dependency (TTD) program at Royal Papworth Hospital. The study aims to assess whether providing support to both patients and their household members improves quit rates and reduces relapse risk.
Participants will receive nicotine replacement therapy (NRT) and behavioural support, with follow-up assessments at 28 days, 3 months, and 12 months after starting the program. This study will compare outcomes to historical data from patients who participated in the TTD program without household support.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Treating Tobacco Dependency (TTD) program is currently available at Royal Papworth Hospital as part of an NHS initiative that started in August 2023. The program is available to all patients who smoke tobacco and are admitted to the hospital for at least 24 hours.
The TTD program provides NRT and behavioural counselling support, initially delivered by the TTD team at Royal Papworth Hospital, followed by HealthyYou, an NHS-approved stop smoking organization. Through this study, investigators are extending the invitation to household members of Royal Papworth Hospital patients to join the TTD program. This will allow the research team to assess whether a household-based intervention improves smoking cessation rates for both patients and their household members.
All participants will be followed up at 28 days, 3 months and 12 months post start of quit smoking. The smoking cessation rate will be compared to the routine TTD data set the research team has previously collected over the last year before household members were approached. This data will be acting as a control.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
- Royal Papworth Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any inpatient aged 18 and above admitted to Papworth Hospital who smoke. (Smoking is described as using any tobacco products as defined by the TTD programme)
- Patient and household members must be eligible to join the TTD programme.
- Patients must live in a household with other smokers.
- Participants must live in Cambridgeshire and/or be registered with a GP Practice in the Cambridgeshire & Peterborough Integrated Care System
Exclusion Criteria:
- Pregnant individuals - Pregnant individuals who smoke are offered a differing pathway to the standard TTD programme.
- Contraindications for NRT.
- Any household member who smokes unwilling to participate.
- Individuals already enrolled on smoking cessation programme.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with household members support
Both the patients and the additional household members will be provided with Nicotine Replacement Therapy products and behavioural support. All participants will be followed up at 28 days, 3 months and 12 months post start Quit Date. The intervention in this study involves inviting household members of the patients, to participate in the Treating Tobacco Dependency program. The control group is patients without household members support. This is based on retrospective data of all patients who were admitted to Papworth Hospital and engaged with the Treating Tobacco Dependency Programme without any household members invited. |
The intervention in this study involves inviting household members of the patients, to participate in the Treating Tobacco Dependency program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quit Rate among patients at 28 days
Time Frame: 28 days
|
Assess difference in quit rates between patients with household support and the control group at 28 days.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient relapse rate
Time Frame: 3 and 12 months
|
Patient relapse rate at 3 and 12 months.
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3 and 12 months
|
|
Household member quit rate
Time Frame: 28 days, 3 months and 12 months
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Household member quit rate at 28 days, 3 months and 12 months.
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28 days, 3 months and 12 months
|
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Difference in relapse rate between patients with and without household members support
Time Frame: 3 months and 12 months
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Difference in relapse rates between the two groups at 3 months and 12 months (Patients supported with household members and the control group)
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3 months and 12 months
|
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Acceptance rate of support among household members
Time Frame: Baseline (At the time of screening , prior to enrollment)
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Potential household members who were approached but did not agree to participate in the study will be analyzed for the Acceptance of Support Among Household Members Who Smoke (%) endpoint
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Baseline (At the time of screening , prior to enrollment)
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Collaborators and Investigators
Investigators
- Study Chair: Health Inequalities Specialist, Royal Papworth Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
- P03172
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
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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