NCT04263545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

18 days

First QC Date

January 29, 2020

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Behavioral: Group session with smoking cessation counsellor

Standard Care

PLACEBO COMPARATOR
Behavioral: Standard Care

Interventions

Group session with smoking cessation counsellor

Intervention
Standard CareBEHAVIORAL

standard care arm will receive very brief advice (VBA) and signposting to local organisations to support a quit.

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 10, 2020

Study Start

June 3, 2019

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

February 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations