The Staff Stop Smoking Project | NCT04263545

Studies
The Staff Stop Smoking Project

NCT04263545

Sponsor

Portsmouth Hospitals NHS Trust

Status

Completed

Last Update Posted

Feb 10, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

Group session with smoking cessation counsellor
Standard Care

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2019Actual

Primary Completion Date

Jun 21, 2019Actual

Completion Date

Jun 21, 2019Actual

First Submitted Date

Jan 29, 2020

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2020

Last Update Posted Date

Feb 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator		Behavioral: Group session with smoking cessation counsellor
Standard Care	Placebo Comparator		Behavioral: Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group session with smoking cessation counsellor	Behavioral	Group session with smoking cessation counsellor	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital		Portsmouth	Hampshire	PO6 3LY	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

meeting with a smoking cessation counsellor to discuss their individual requirements for smoking cessation and be offered their choice of pharmacological intervention. They will be provided with their choice of pharmacotherapy on site.They will then be invited to attend a group session, where they will have some brief lung function tests and check carbon monoxide levels. Participants will be offered refreshments and receive a bespoke group session to address various aspects of smoking cessation.

Masking Info

Masking

None (Open Label)

Masking Description

Participants who are randomised to the standard care arm will receive very brief advice (VBA) and signposting to local organisations to support a quit smoking.

Who Masked

Not provided