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

Active, not recruiting

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

Interventional

Enrollment (Estimated)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Royal Papworth Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)
  2. Patient and household members must be eligible to join the TTD programme.
  3. Patients must live in a household with other smokers.
  4. Participants must live in Cambridgeshire and/or be registered with a GP Practice in the Cambridgeshire & Peterborough Integrated Care System

Exclusion Criteria:

  1. Pregnant individuals - Pregnant individuals who smoke are offered a differing pathway to the standard TTD programme.
  2. Contraindications for NRT.
  3. Any household member who smokes unwilling to participate.
  4. Individuals already enrolled on smoking cessation programme.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
3 and 12 months
Household member quit rate
Time Frame: 28 days, 3 months and 12 months
Household member quit rate at 28 days, 3 months and 12 months.
28 days, 3 months and 12 months
Difference in relapse rate between patients with and without household members support
Time Frame: 3 months and 12 months
Difference in relapse rates between the two groups at 3 months and 12 months (Patients supported with household members and the control group)
3 months and 12 months
Acceptance rate of support among household members
Time Frame: Baseline (At the time of screening , prior to enrollment)
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
Baseline (At the time of screening , prior to enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Health Inequalities Specialist, Royal Papworth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2025

Primary Completion (Actual)

April 22, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 22, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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