The Staff Stop Smoking Project (STOP)

A Randomised Feasibility Study Comparing a Novel Intervention for Smoking Cessation in NHS Staff to Standard Care

Participants will be randomised to either standard care or to receive our help to quit programme. The study will only be available to Portsmouth Hospital Trust staff member.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Group session with smoking cessation counsellor; Behavioral: Standard Care

Detailed Description

A randomised controlled feasibility study to trial a novel intervention to help NHS staff stop smoking compared to standard care. Participants will attend one-on-one interviews and a support group where they will undertake CO monitoring and mini-spirometry. They will complete questionnaires about their quality of life, other health problems and their general state of health. They will attend the support groups on a weekly basis and have access to support outside of these times.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female, aged 18 years or over
• Willing and able to give informed consent for participation in the study.
• Must work for PHT at QAH and be able to attend weekly meetings for the duration of the study period
• Must be a current smoker

Exclusion Criteria:

-Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention	Behavioral: Group session with smoking cessation counsellor; Group session with smoking cessation counsellor
PLACEBO_COMPARATOR: Standard Care	Behavioral: Standard Care; standard care arm will receive very brief advice (VBA) and signposting to local organisations to support a quit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioural outcomes	Number of smokers who achieve a successful quit	4 weeks
Behavioural outcomes	Number of smokers who achieve a successful quit	12 weeks
Behavioural outcomes	Number of smokers who achieve a successful quit	6 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2019
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (ACTUAL): February 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PHT/2019/17

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